Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery

ABSTRACT

The invention is methods and devices which a surgeon may use to stabilize the beating heart during a surgical procedure on the heart. Pursuant to the invention, a stabilizing device is introduced through an opening in the chest and brought into contact with the beating heart. By contacting the heart with the device and by exerting a stabilizing force on the device, the motion of the heart caused by the contraction of the heart muscles is effectively eliminated such that the heart is stabilized and the site of the surgery moves only minimally if at all. Typically, in separate steps, the surgeon contacts the heart with the stabilizing means, assesses the degree of movement of the anastomosis site, and exerts a force on the stabilizing means such that the contraction of the beating heart causes orgy minimal excess motion at the surgery site. By fixing the position of the stabilizing means in a configuration where the motion of the beating heart is effectively eliminated, the surgeon is able to stabilize the beating heart for the duration of the procedure. The stabilizing means may be attached to a rigid support or may be attached to a semi-rigid support which is rendered motionless mechanically, chemically, or by human intervention. In certain preferred embodiments, the stabilizing means is affixed to a semi-rigid support which is caused to become rigid, by any of a variety of techniques, such that the position of the stabilizing means becomes fixed by the support, and the heart remains substantially motionless for the duration of the procedure.

The present application is a continuation of U.S. application Ser. No.08/789,751 filed Jan. 27, 1997 and titled “Surgery Instruments andProcedures for Stabilizing the Beating Heart During Coronary ArteryBypass Graft Surgery”, now U.S. Pat. No. 6,346,077, which is acontinuation-in-part of U.S. application Ser. No. 08/603,758 filed onFeb. 20, 1996 which is now U.S. Pat. No. 5,894,843 filed Apr. 20, 1999.U.S. application Ser. Nos. 08/789,751 and 08/603,758 and U.S. Pat. No.5,894,843 are hereby incorporated by reference thereto, in theirentireties.

Diseases of the cardiovascular system affect millions of people eachyear and are a leading cause of death throughout the world. The costs tosociety from such diseases is enormous both in terms of the lives lostand in terms of the cost of treating patients through traditionalsurgical techniques. A particularly prevalent form of cardiovasculardisease is a reduction in the blood supply leading to the heart causedby atherosclerosis or other condition that creates a restriction inblood flow at a critical point in the cardiovascular system thatsupplies blood to the heart. In many cases, such a blockage orrestriction in the blood flow leading to the heart is treated by asurgical procedure known as a Coronary Artery Bypass Graft (CABG)procedure, which is more commonly known as a “heart bypass” operation.In the CABG procedure, the surgeon “bypasses” the obstruction to restorenormal blood flow to the heart by attaching an available source vesselto an obstructed target coronary artery or by removing a portion of avein or artery from another part of the body, to use as a graft, and byinstalling the graft at points between a source vessel and a targetartery to restore normal blood flow.

Although the CABG procedure has become relatively common, the procedureitself is lengthy and traumatic and can damage the heart, thecardiovascular system, the central nervous system, and the blood supplyitself. In a conventional CABG procedure, the surgeon must make a longincision down the center of the chest, cut through the entire length ofthe sternum, perform several other procedures necessary to attach thepatient to a heart-lung bypass machine, cut off the blood flow to theheart, and then stop the heart from beating in order to complete thebypass. The most lengthy and traumatic surgical procedures arenecessary, in part, to connect the patient to a cardiopulmonary bypass(CPB) machine to continue the circulation of oxygenated blood to therest of the body while the bypass is completed.

Although several efforts have been made to make the CABG procedure lessinvasive and less traumatic, most techniques still requirecardiopulmonary bypass (CPB) and cardioplegia (stopping the heart). Thesafety and efficacy of the CABG procedure could be improved if thesurgeon could avoid the need to stop the heart from beating during theprocedure, thereby eliminating cardiopulmonary bypass and the lengthyand traumatic surgical procedures necessary to connect the patient to acardiopulmonary bypass machine to sustain the patient's life during theprocedure. In recent years, a small number of surgeons have begunperforming CABG procedures using surgical techniques especiallydeveloped so that the CABG procedure could be performed while the heartis still beating. In such procedures, there is no need for any form ofcardiopulmonary bypass, no need to perform the extensive surgicalprocedures necessary to connect the patient to a cardiopulmonary bypassmachine, and no need to stop the heart. As a result, the surgery is muchless invasive and the entire procedure can typically be achieved througha small number, typically one or two, comparatively small incisions inthe chest.

Despite the advantages, the beating-heart CABG procedure is not widelypracticed, in part, because of the difficulty in performing thenecessary surgical procedures using conventional surgical instruments.If specially designed instruments were available so that the CABGprocedure could be performed on the beating heart, the beating-heartCABG procedure would be more widely practiced and the treatment ofcardiovascular disease in a significant patient population would beimproved.

As noted above, the CABG procedure requires that a fluid connection forrestoring the flow of blood be established between two points to“bypass” a diseased or obstructed area to restore blood flow to theheart. This procedure is known as an “anastomosis.” Typically, a sourcevessel, such as a source artery with an unobstructed blood flow, i.e.,the left internal mammary artery (LIMA), or a bypass-graft having oneend sewn to an unobstructed blood source such as the aorta, is sewn to atarget occluded coronary artery, such as the left anterior descending(LAD) artery or other vessel, that provides blood flow to the muscles ofthe heart. Because the beating-heart CABG procedure is performed whilethe heart muscle is continuing to contract and pump blood, theanastomosis procedure is difficult to perform because the heartcontinues to move while the surgeon is sewing the anastomosis.

The specific part of the surgical procedure that creates the anastomosisin the beating-heart CABG procedure requires placing a series of suturesthrough extremely small vessels on the surface of the heart and requirescompleting the anastomosis while the heart muscle continues to beat topump blood during the procedure. Moreover, the sutures must be carefullyplaced so that the source vessel or graft is firmly attached when theanastomosis is complete and does not leak when blood flow through thevessel is established. It is also important that the anastomosisprocedure be performed rapidly because the blood flow through the targetcoronary artery may be temporarily interrupted or reduced to avoidexcessive blood loss. Also, the working space and visual access arelimited because the surgeon may be working through a small incision inthe chest or may be viewing the procedure on a video monitor if the siteof the surgery is viewed via a surgical scope.

In one current practice, the surgeon places sutures through the hearttissue and, by exerting opposing tension on the sutures, stretches thetissue surrounding the site of the anastomosis to partially reduce themotion of the heart while the anastomosis is completed. This approach isfar from ideal. Alternatively, a suction device may be attached to thesurface of the heart to fix the motion of the outer layer of surfacetissue. In such cases, a suction device typically has several portsincorporated into an instrument that may be attached to the heart toapply a negative pressure to the surface tissue. The negative pressureessentially attaches the surface tissue to the apparatus thereby fixingthe position of a portion of the surface of the heart Such devices aredescribed in co-pending U.S. patent application Ser. No. 603,328.

While the negative pressure approach may be effective in fixing aportion of the surface tissue of the heart, the negative pressureapplied to cardiac tissue can result in temporary hematomas at the sitewhere the suction ports attach to the tissue. Also, the exterior cardiactissue is fixed in a configuration defined by the shape of theinstrument and the orientation of the suction ports. While the heartcontinues to beat, the heart muscles are contracting to pump blood,which results in the muscles exerting a force directed away from theexterior tissue fixed by suction.

The beating-heart CABG procedure could be greatly improved if the heartcould be stabilized during the procedure such that the motion of theheart, particularly at the site of the anastomosis, is minimized eventhough the heart continues to beat to supply blood to the body. Ifeffective means for stabilizing the beating heart were available, thebeating-heart CABG procedure could be performed more easily, morerapidly, more safely, and with less trauma to the patient.

SUMMARY OF INVENTION

The advantages provided to a surgeon by the instruments and techniquesof the invention allow the beating heart CABG procedure to be performedmore rapidly, with less trauma to the patient, and enable a surgeon toperform a CABG procedure without CPB or cardioplegia. This inventionprovides an alternative approach to a suction apparatus by providingdevices and methods for stabilizing the motion of the heart usingmechanical instruments specially designed to apply a stabilizing forceto the heart to minimize the motion of the beating heart during asurgical procedure. The invention enables a surgeon to readily andrapidly perform a beating-heart CABG procedure thus avoiding the needfor cardioplegia or cardiopulmonary bypass. In particular, the methodsand devices described herein enable the surgeon to stabilize the heartsuch that an anastomosis can be more readily accomplished by enablingthe surgeon to attach a source vessel or bypass graft to a targetcoronary artery whose motion is minimized for the duration of thesurgical procedure.

Pursuant to the invention, a stabilizing device is introduced through asuitable opening in the chest that provides access to the beating heart.By contacting the heart with the means for stabilizing the beating heartof this invention, and by exerting a stabilizing force on the heart, themotion of the heart caused by the contraction of the heart muscles iseffectively eliminated such that movement of the target artery at thesite of the anastomosis is minimized. The remainder of the heart may beallowed to contract normally or may have additional devices in place tosupport the heart or to restrain its motion. Additionally, several ofthe devices of the invention may be used to position the beating heartto provide an improved surgical field, to maintain the heart in apreferred configuration for surgery, or to rotate the heart to presentdistinct features of the heart to the surgeon's visible and accessiblesurgical field.

An important advantage of this invention is derived from the discoverythat a new and effective technique can be described herein and performedin surgery using the devices of the invention to provide an advantageoustechnique for stabilizing or positioning the beating heart during asurgical procedure. The procedure for stabilizing the beating heartgenerally requires exerting a stabilizing force on the beating heartusing devices constructed as described herein Typically, in separatesteps, the surgeon contacts the heart with at least one component of themeans for stabilizing the beating heart of this invention, assesses thedegree of movement of the heart, particularly at the site of thesurgery, and positions the component of the stabilizing means proximateto the site of the surgery such as a target coronary artery of ananastomosis. With the functional portion of a stabilizing means inplace, the surgeon applies a stabilizing force to the beating heart suchthat the portion of the instrument in contact with the surface of theheart displaces the surface of the heart a sufficient distance that thecontraction of the heart does not cause substantial motion, eithervertical or horizontal, at the surgery site. The stabilizing force isapplied directly or indirectly using at least one component of thestabilizing means of the invention and is comprised of exerting amechanical force onto the beating heart, generally at a specificlocation such as a target coronary artery and generally exerting forcethat is at least partially applied in a direction perpendicular to thesurface of the beating heart. Thus, an important aspect of thisinvention is the discovery that the beating heart may be effectivelystabilized for the purpose of a surgical procedure by using a speciallydesigned instrument as described herein to exert a mechanicalstabilizing force on the exterior of the heart, particularly where theforce is exerted proximate to the site of the surgery. The stabilizingforce may consist of a force that resists the motion supplied by thebeating heart, or additional forces applied to the heart, or thestabilizing force.

By fixing the position of the stabilizing means in a configuration wherethe motion of the beating heart is effectively eliminated, the surgeonmaintains the stabilizing force on the beating heart for the duration ofthe procedure. To fix the position of the means for stabilizing thebeating heart, the stabilizing means may be attached to a retractor usedto separate the ribs or to another fixed support. The stabilizing meansmay also be attached to a comformable, flexible, or semi-rigid arm orshaft means which is rendered substantially rigid mechanically,chemically, or by human intervention. In certain preferred embodiments,the stabilizing means has an adjustable shaft means which may beoriented in several directions and has a fixture adapted to be attachedto a retractor. In a preferred technique of the invention, the surgeonfirst performs a thoracotomy and retracts the ribs using a retractor,which may then be locked in an open position providing access to thebeating heart. The surgeon then contacts the surface of the heart with acomponent of the stabilizing means, which has been provided with anadjustable shaft, at a point proximate to the target coronary artery,and exerts a stabilizing force on the means for stabilizing the beatingheart. By manipulating the adjustable shaft, the site of the surgerywill become substantially motionless. This force may be advantageouslyapplied, and the absolute amount of force minimized with the additionalfeature of an adhesive or high-friction surface on the component of thestabilizing means that contacts the beating heart. At this point, theadjustable shaft means is fixed in position, for example by being stablyattached to the retractor, thereby rendering the target coronary arterysubstantially motionless for the duration of the procedure.

DESCRIPTION OF THE FIGURES

FIG. 1 is a means for stabilizing the beating heart having a pair ofsubstantially planar contact members which are oriented to engage theheart proximate to the site at which a bypass will be sewn. FIG. 1 alsoshows the contact members attached to a shaft means which may beadjustable in several directions and which may be attached to aretractor or other fixed support structure.

FIG. 1A is a detail of the shaft means and the structure of theadjustable positioning mechanisms.

FIGS. 1B through 1G are various configurations of a contact memberhaving a friction means which is preferably affixed to the bottomsurface of the contact member.

FIG. 2 is an example of a snap-on member affixed to the bottom surfaceof a contact member for ease of manufacture and disposabilityadvantages.

FIG. 3 is an example of a stabilizing means of the invention having aninflatable or fluid-filled cushioning member disposed between the bottomsurface of the contact member and the surface of the beating heart.

FIGS. 4A through 4C are an embodiment of the invention having weightedcontact members that engage the beating heart, and which may be part ofa system to achieve stabilization of the heart by applying a stabilizingforce via a balanced mass having an adjustable weight and counterweightconfiguration. FIG. 4A shows the weighted contact member in crosssection. FIG. 4B is the contact members having an opening disposedtherebetween for positioning of a vessel. FIG. 4C shows the contactmember coupled to a shaft that is affixed to a fulcrum having anadjustable weight and a counter-weight.

FIG. 5 is an embodiment of the invention having a counter-contact memberpositioned opposite a pair of contact members and having a shaftpositioned at an intermediate point therebetween.

FIGS. 6A and 6B are embodiments of the invention having contact memberswhich have a conformable shape, and where a flexible or semi-rigidmember may be passed through the body of the contact member.

FIG. 7A is an embodiment of the contact member wherein the contactmember has ports for releasable attachment of the distal end of a shaftmeans.

FIG. 7B is an embodiment wherein a plurality of ports are disposed aboutthe periphery of a contact member for releasable attachment to thedistal end of a shaft means.

FIG. 7C is an embodiment of the invention wherein a separate shaft isprovided having distal portions adapted to fit within ports on a contactmember.

FIGS. 7D and 7E are an embodiment of the invention wherein the contactmembers are formed from the distal portion of a shaft means forminimally invasive applications. FIG. 7E shows an interconnecting memberfor joining the distal portions of the shaft means.

FIG. 8 is an embodiment of the invention having a substantially annularcontact member which is affixed to a shaft which is rotatable about theannular contact member and which may be locked into position at a givenpoint about the periphery of the contact member.

FIGS. 9A through 9G are embodiments of the invention where a positive ornegative pressure is provided proximate to the contact members.

FIG. 9H is an embodiment of the invention where a light source isprovided to illuminate the area that the beating heart contacted by thecontact members.

FIGS. 10A through 10C are embodiments of the invention where a surgicaldrape is operably associated with the contact members to provide anisolated visual field.

FIG. 11 is the contact members of the invention having an associatedapparatus to facilitate completing the anastomosis.

FIG. 12 is an embodiment of the invention where the shaft means hasassociated therewith a separate vessel holder.

FIGS. 13A through 13E are a cannula assembly preferred for providingminimally invasive access for the stabilizing means of the invention.FIG. 13A has screws for attaching the cannula assembly to the chestwall. FIG. 13B has a threaded portion about the periphery of thecannula. FIGS. 13C through. 13E are a locking mechanism designed toengage adjacent ribs.

FIG. 14 is a conical cannula having a smaller distal end to engage thesurface of the beating heart and a larger proximal opening forintroducing surgical instruments to the beating heart.

FIGS. 15A and 15B are an embodiment of the invention inserted throughthe chest wall in a minimally invasive fashion via a cannula to bringthe contact members into engagement with the beating heart.

FIGS. 16A through 16E are an embodiment of the invention design forminimally invasive insertion and removal of flexible contact memberswhereby the contact members are maintained in a retracted state within ahollow portion of a shaft and are deployed upon extension of a centralshaft.

FIGS. 17A through 17D are an additional embodiment providing minimallyinvasive insertion and removal of the contact members of the inventionwhereby individual contact members are rotated into position by a hingeat the distal end of a shaft.

FIGS. 18A through 18D are contact members which are attached to a guidethat is positioned about a shaft such that downward movement of theguide causes the contact members to be deployed.

FIGS. 19A and 19B are contact members of the invention attached to ashaft means by a plurality of struts that extend the contact membersinto position.

FIGS. 20A through 20E are contact members of the invention that arerotatable about the distal portion of a shaft means by a plurality ofhinges.

FIGS. 21A through 21C are an embodiment having contact members formedfrom a unitary wire which is looped such that when extended from a bodyof the device, the contact members are deployed, and may be removed in aminimally invasive fashion by withdrawing a portion of the wire into thebody of the device.

FIGS. 22A through 22C are an embodiment of the invention wherein thecontact members are formed from a helical coil which may be withdrawninto the hollow portion of a shaft for minimally invasive insertion andremoval.

FIGS. 23A and 23B are inflatable contact members that may be deflatedfor insertion or removal by being drawn into the body of a shaft.

FIGS. 24A and 24B are a contact member of the invention formed from aninflatable annular cuff.

FIGS. 25A and 25B are contact members formed from the divided portion ofthe distal end of a shaft.

FIGS. 26A through 26C are contact members having sutures associatedtherewith for manipulation of a target artery.

FIGS. 27A and 27B are an intravessel stabilizer adapted to fit withinthe target coronary artery.

FIGS. 28A and 28B are contact members of the invention having meansassociated therewith for positioning said epicardial tissue.

FIGS. 29A and 29B are contact members of the invention having rotatablecylindrical rollers for collecting or spreading epicardial tissueproximate to a target artery.

FIG. 30 is a means for stabilizing the beating heart having a pair ofcontact members which are additionally comprised of a spring-tensionedframe having an extension that engages and spreads the tissue at thesite of the surgery to better expose the coronary artery.

FIGS. 31A and 31B are embodiments of the stabilizing means having asingle shaft means associated with each contact member and where theshaft means are interconnected and can be moved independently about apivot such that the contact members spread the surface tissue of theheart proximate to the target coronary artery to increase exposure ofthe target artery at the site of the anastomosis.

FIGS. 32A through 32C are embodiments of the invention wherein thecontact members have additional structures associated therewith forretraction of epicardial tissue, the epicardial retractors may becomprised of pins which extend from the bottom surface of the contactmember.

FIGS. 33A and 33B are means for stabilizing the beating heart comprisinga system which incorporates the retractor which spreads the ribs toprovide surgical access to the heart. The stabilizing means is comprisedof a pair of stabilizing plates which may be used together with a leverdevice to improve exposure of the target coronary artery.

FIGS. 34A through 34D are an embodiment of the invention having alockable mechanism for depressing epicardial tissue on either side of atarget coronary artery.

FIG. 35 is a substantially planar stabilizing platform which contactsthe heart at a site proximate to and surrounding the coronary vessel.The platform may also have associated therewith at least one occluderwhich restricts or eliminates blood flow through an artery and anassociated device for spreading the tissue proximate to the anastomosis.

FIG. 36 is an artery occluder comprised of a shaft portion and having ablunt portion to engage a target artery.

FIGS. 37A through 37C are contact members having structures associatedtherewith for occluding the target coronary artery.

FIGS. 38A and 38B are contact members of the invention having a flangeassociated therewith for use with sutures that surround the targetvessel and may be used in connection with a movable shaft or sutureguide to occlude the target vessel.

FIG. 39 is an embodiment of the contact member of the invention havingone or more fixtures attached, preferably to a planar surface thereof,and adapted to receive a surgical tool or accessory such as scissors,forceps, or surgical needles for the convenience of the surgeon duringthe anastomosis procedure.

FIG. 40 is an embodiment of the invention having flex joints between thecontact members, the interconnecting shaft, or the shaft means toprovide continuous positioning of the contact members.

FIG. 41 is an embodiment of the invention having lockable jointsassociated with the shaft means.

FIG. 42 is a flexible, lockable arm which allows positioning in everydirection to place and orient the contact members until the requisitedegree of stabilization is achieved at which point the arm having astabilizing means is fixed in position. The flexible, lockable arm maybe attached to a retractor and is caused to become rigid when the entirestabilizing means is properly positioned.

FIG. 43 is a conformable, lockable arm having hollow cylinders andspheres and an inflatable balloon member disposed therein to lock thearm into position.

FIGS. 44A and 44B are embodiments of the invention having curvedinterlocking segments wherein teeth formed at the interconnectingsurfaces of each segment prevent rotation of the respective segments.

FIGS. 45A and 45B are a flexible shaft having means incorporated thereinfor fixing the position of the shaft.

FIGS. 46A through 46C are an embodiment of the invention where a seriesof adjustable links have a elastomeric hydraulic median disposed thereinand where application of force causes the elastomeric hydraulic medianto become rigid and fixes the position of the adjustable links.

FIG. 47 is an embodiment of the invention having a flexible shaft with aplurality of strands located therein wherein locking the strands inposition at a distal portion causes the shaft to become rigid.

FIG. 48 is a flexible shaft having a plurality of lumens disposedtherein such that sealing of the lumens fixes the position of theflexible shaft.

FIG. 49 is a fine adjusting mechanism wherein a plurality of threadedcables are attached to a proximal portion of a shaft means wherebyturning the threaded cables causes the proximal portion of the shaftmeans to be adjusted.

FIGS. 50A and 50B are embodiments of the shaft means havingspring-loaded or air-damping mechanisms to restrict the vertical motionof the shaft relative to a stable support.

FIGS. 51A and 51B are shaft means of the invention provided with fineadjustment mechanisms for vertical positioning of the shaft.

FIG. 52 is a malleable shaft that is mounted on a fixture attached to aretractor blade and having a handle for vertical positioning of theshaft.

FIG. 53 is a shaft means comprised of an adjustable arm formed fromseveral interlocking segments attached to a cable.

FIGS. 54A through 54C are an adjustable shaft means of the inventionwherein the position of the contact members are adjusted by apositioning handle located at the proximal portion of the shaft meansand connected to a ball joint at the distal portion by a plurality ofpositioning wires.

FIG. 55A is an embodiment of the stabilizing means of the inventionhaving stabilizer bars suspended from the bottom side of a rib retractorwherein the stabilizer bars engage a ratchet means.

FIG. 55B has malleable shafts attached to a retractor and to the contactmembers.

FIGS. 56A through 56D are a shaft means of the invention havingmechanisms for adjustable positioning of the shaft relative to a stablesupport.

FIG. 57 is an adjustable arm for attaching a shaft means of theinvention to a stable support wherein the shaft means passes through aball joint that is adjustable by a fixture on the arm and wherein thearm is locked in place on the stable support by a latch mechanism.

FIGS. 58A through 58C are embodiments of the shaft means of theinvention for adjustable positioning of the shaft means relative to aretractor blade.

FIGS. 59A through 59C are adjustable shaft means of the invention thatextend from a retractor blade or a retractor arm and are continuouslypositioned relative to the retractor blade or retractor arm.

FIG. 60 is an embodiment having a central shaft with a handle at theproximal end that is positioned by a plurality of shaft guides which arepreferably attached to a interconnecting arm affixed to a retractor.

FIG. 61 is an embodiment of the stabilizing means of the inventionhaving a pair of plates operably associated with a rib retractor and asphere disposed between the plates to facilitate orientation of theshaft means.

FIG. 62 is an embodiment of the invention having a shaft means comprisedof an arm which extends from the interconnecting bar of a retractor to aposition below the retractor blades and has a substantially horizontalshaft.

FIG. 63 is the means for stabilizing the beating heart of the inventionoperably associated with a rib locking mechanism.

FIG. 64 is the stabilizing means of the invention adapted to be used asa means for positioning the beating heart, wherein the means areoperably associated with a rib locking mechanism.

FIGS. 65A through 65D are embodiments of the invention where the shaftmeans is comprised of a unitary hollow shaft.

FIG. 66 is a means for stabilizing the beating heart having a sheathmember with several pliable support attachments associated therewithwhich may include or be comprised of inflatable members which arepositioned at one or several locations surrounding the heart and mayhave a lumen disposed within the sheath member for the introduction ofair or a biocompatible fluid.

FIG. 67 is a stabilizing means formed from a movable sheath member thatis attached at either end to cranks mounted on the arms of a retractor.

FIGS. 68A through 68C are a device for advantageous positioning of theheart comprised of a flexible sheet, preferably having a hydrogelcoating on one side.

FIG. 69 is an embodiment of the invention comprised of a plurality oftelescoping shafts having the contact member affixed at their distal endand wherein the position of the telescoping shaft is manipulated andfixed by a hydraulic actuators.

FIG. 70A through 70D are an embodiment of the invention having aconformable arm comprised of a plurality of friction joints that areengaged when the motion of the beating heart presses against the contactmember.

FIGS. 71A through 71D are an embodiment of the invention having acontractible shaft attached to a flexible slide. The flexible slide isdesigned to be inserted into a seed-shaped clip which may be attached toa retractor blade. The contractible shaft is extended to engage thebeating heart by application of hydraulic pressure, for example, by asyringe that is preferably supplied with a one-way releasable valve.

FIG. 72 is a view of the interior of the chest cavity during a CABGprocedure on the beating heart with the stabilizing means operablyassociated with a retractor and being used in conjunction with othersurgical apparatus to facilitate completing the anastomosis.

FIGS. 73 and 74 show the stabilizing means of the invention having beenintroduced through a thoracotomy to contact the beating heart to engagethe heart tissue on either side of a target coronary artery to which ananastomosis is sewn.

FIG. 75 is an embodiment of the invention having a pair of shaft meansoperably associated with ball joints that are affixed to opposing armsof a retractor.

DETAILED DESCRIPTION OF THE INVENTION

This invention is surgical instruments for stabilizing the beating heartand methods for their use. The means for stabilizing the beating heartare comprised of several alternative structures at least one componentof which engages the surface of the heart to stabilize the beating heartduring coronary surgery. The instruments provide the capability to exertand maintain a stabilizing force on the heart by contacting the heartwith a component of the stabilizing means and by functionally fixing theposition of the stabilizing means throughout the duration of a surgicalprocedure.

The instruments and methods of the invention are preferably used forstabilization of the beating heart during a minimally invasive coronaryartery bypass graft (CABG) operation which has been specially developedto facilitate completion of an anastomosis, to a target coronary arteryfor example by the placement of a bypass graft or the connection of asource artery, without requiring cardiac arrest such as cardioplegia orfibrillation and without cardiopulmonary bypass (CPB). Although themeans for stabilizing the beating heart can be applied in differentsurgical contexts, the devices described herein are most advantageouslyemployed in a CABG procedure wherein only one or two minimally invasiveincisions are placed in the chest. The complete structure of thestabilizing means of the invention may be provided by any of severalstructural embodiments which stabilize the beating heart while theminimally invasive surgical procedure is performed. Discrete componentsof the stabilizing means may also advantageously function in a multiplecomponent system containing a retractor, an occluder, a surgical bloweror suction device, an apparatus for holding the source artery, such as aLIMA holder, or other like discrete or integrated surgical devices orinstruments that enable a surgeon to more efficiently complete theanastomosis. While the devices disclosed herein each use mechanicalmeans to stabilize the beating heart, certain embodiments are designedto operate on the entire heart while others have a more localized effectand may be applied to the area immediately proximate to a structure suchas the target artery of the anastomosis. In each instance, the beatingheart is effectively stabilized at the area where a surgical procedureis to be performed.

Surgical access to the beating heart may be achieved by severalconventional surgical procedures which have been developed fortraditional cardiac bypass surgery and the surgeon may thereby obtainthe advantages provided by this invention in any procedure where thebypass is achieved on the beating heart without regard to the surgicalmethod of access to the heart. Preferably, the surgeon takes additionalmeasures to restrict the movement of the entire heart within the chestcavity and may utilize certain embodiments disclosed herein to positionor orient the beating heart. For example, an adjustable strap which mayhave inflatable cushions attached to the straps, or having laces may beinserted beneath or surrounding the heart. When access to the beatingheart is achieved by a sternotomy, at least part of the length of thesternum is divided to expose the surface of the heart. Additionally,when the pericardium is available, the pericardium may be incised andused to position the beating heart. When available, the surgeon can usethe pericardium to raise and rotate the beating heart within the chestcavity and maintain the position by suturing the pericardium to theperiphery of the incision.

In a preferred embodiment, minimally invasive access to the beatingheart is achieved by a thoracotomy, which is usually created in the leftside of the chest by a smaller incision between the ribs, followed byinsertion of a retractor between the ribs, spreading of the ribs, andsecuring the retractor in an open position to provide access to thesource vessel and the target coronary artery. The use of the pericardiumto position the beating heart as described above is particularlyadvantageous when the less invasive thoracotomy is used to provideaccess to the heart. In this procedure, an incision is created in thepericardium, which is then sutured to the periphery of the thoracotomy.In this configuration, the pericardium acts as a restraining sack tokeep the beating heart in a desired orientation to achieve theanastomosis.

Once access to the heart is achieved, and the heart is positioned ifnecessary, the means for stabilizing the beating heart is introducedthrough the opening created by the thoracotomy and at least onecomponent of the stabilizing device of the invention is brought intocontact with the beating heart. The surgeon then applies a stabilizingforce to the beating heart via the stabilizing means which may then befixed in place by attachment to a fixed support. When the rib retractoror platform is fixed in an open position to expose the heart, theretractor platform may also provide the stable support structure towhich the stabilizing means is affixed. When the position of thestabilizing means is fixed by attachment to a stable support or to theretractor platform, the stabilizing force is maintained for the durationof the procedure.

Although the particular source vessel and target artery of theanastomosis are determined clinically, a common minimally invasivebypass procedure on the beating heart includes an anastomosis whichforms a connection between the left internal mammary artery (LIMA) asthe source artery, and the left anterior descending artery (LAD) as thetarget artery. The LIMA to LAD anastomosis is used as an example hereinbut it is readily appreciated that the techniques and instrumentsdescribed herein may be applied to other procedures depending on theclinical diagnosis and a patient's anatomy. To complete the anastomosis,the surgeon must dissect a portion of the LIMA by separating it from theinternal chest cavity. Once dissection of the LIMA is achieved, thesurgeon may attach the dissected LIMA to the target coronary artery,i.e., the LAD. In this example, the stabilizing means of this inventionwould be used to stabilize the beating heart during at least the portionof the procedure during which the surgeon completes the anastomosis ofthe LIMA to the LAD.

The structure of the portion of the stabilizing means which contacts theheart may include one or more contact members which exert a stabilizingforce on the heart proximate to the site of the anastomosis. A pair ofcontact members may be plates or rectangular members which are placed oneither side of the target coronary artery at the site of the anastomosisand which may have friction means or tissue spreading or compressingapparatus associated therewith. The contact members may also be providedby a platform which may be substantially planar or which may becontoured to fit conformingly on the surface of the heart. Thestabilizing means may also include a shaft means having severalalternative embodiments to facilitate adjusting the position andorientation of the instrument. For example, the shaft means may have anadjustable length and the axis of the shaft means may have at least oneball joint disposed within its length such that the orientation of theshaft means relative to another structure such as the contact members orstable support may be continuously varied. As is apparent from thedescription of the several embodiments, each of the individualembodiments described and illustrated herein has discrete components andfeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments without departing fromthe scope or spirit of the invention.

Referring to FIG. 1, a means for stabilizing the beating heart iscomprised of one or more, and preferably two, contact members 1, whichare attached to a rigid, or semi-rigid connecting shaft 2 which is inturn connected to shaft means 3. The contact members 1 may besubstantially planar, may be slightly curved to conform to the shape ofthe heart, or may be a non-conforming curve to establish contact betweenonly a portion of the contract member 1 and the beating heart. Thecontact members 1 may have any of several alternate shapes includingcylindrical members, members formed into a U-shape, or may comprise apair of substantially parallel members spaced apart in a parallelconfiguration such that a target artery can be positioned between thecontact members. The shape of the contact members may be varieddepending on the clinical assessment by the surgeon, the design of theother features of the stabilizing means, or the design of otherinstruments used to complete the anastomosis. In some embodiments, asdescribed herein, the contact members 1 may have apertures, openings orattachments to facilitate connection with sutures or other devices toachieve the requisite stabilization, occlusion of the target vessel, orexposure of the target vessel. In a preferred embodiment, a pair ofsubstantially planar rectangular contact members 1 are attached at oneend to a continuous connecting shaft 2 and are oriented in asubstantially parallel fashion such that a target cardiac artery ispositioned therebetween and passes along the greater length of thecontact members 1 when the stabilizing means engages the heart. SeeFIGS. 72 through 74. The connecting shaft 2 may be a continuous shaftfor interconnection of the contact members 1 without touching the arteryor may include an additional member which may be operated to contact thetarget artery positioned between the contact members 1, see FIGS. 36through 38, to occlude the passage of blood through the target artery.The contact members 1, connecting shaft 2, and shaft means 3 may becomposed of any non-toxic material such as a biocompatible plastic orstainless steel, having sufficient tensile strength to withstand astabilizing force exerted on the heart via manipulation or fixation ofthe shaft means 3 to cause the contact members 1 to exert a stabilizingforce on the beating heart. Also, while the contact members 1 may eachbe connected to the connecting shaft 2 at one end, with the connectingshaft 2 operably attached to the shaft means 3, each of the individualcontact member embodiments described and illustrated herein has discretefeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments, such as differingdesigns of the shaft means, or other components of the invention by oneof ordinary skill in the art.

The shaft means 3 may be a simple rigid post or may be comprised of amulti-component system designed to be adjustable in length andorientation at least one point along its length. Thus, the length of theshaft means 3 and the orientation of the contact members 1 at the distal(lower) end of the shaft means 3 can be altered by the surgeon.Preferably, the length and orientation at the shaft means 3 relative tothe contact members 1 can be adjusted by controls located at theproximal (upper) end of shaft means 3. (As used herein, the term“distal” refers to a portion of a device most proximal to the heartwhile the term proximal refers to the opposite portion which may extendoutside of the incision and which is most often readily manipulated bythe surgeon). This design provides the advantage that the surgeon canintroduce the stabilizing means to the beating heart by placing thecontact members 1 on the surface of the heart, followed by thecombination of exerting a stabilizing force and locking the contactmembers 1 in place relative to the shaft means 3. Furthermore, thesurgeon may then lock the shaft means 3 into a fixed position byattachment to a stable support such as the retractor, therebymaintaining the stabilizing force for the duration of the procedure. Inone embodiment, the shaft means 3 has a housing 11 whose overall lengthis adjustable by a telescoping release operated by an annular thumbscrew8 which tightens about the housing 11. The position and orientation ofthe contact members 1 relative to the shaft means 3 is adjustable byvirtue of a locking ball joint 5 which is interposed between theconnecting shaft 2 and which is located at the distal end of shaft means3. The locking ball joint 5 allows the position of the shaft means 3 tobe positioned with three degrees of freedom relative to the contactmembers 1.

Referring again to FIG. 1, a locking ball joint 5 is provided byincluding a block 6 within the shaft means 3 which conformingly contactsthe ball joint 5 and fixes the position of the ball joint 5. Block 6 iscompressed against ball joint 5 when a threaded push block 7, connectedto a long telescoping keyed shaft and socket combination 9, and isactuated by means such as a thumbscrew 8 at the upper end of the shaftmeans 3. In operation, a rotation of the top thumbscrew 8 loosens thelower ball joint 5 to allow continuous positioning of the shaft means 3relative to the contact members 1, and a counter-rotation locks the balljoint 5 into place, fixing the position of the contact members 1relative to shaft means 3.

The upper end of shaft means 3 may also have associated therewith anupper ball joint 13 such that the shaft means 3 can be oriented withfour degrees of freedom relative to a fixed support such as a retractor(not shown). The position and orientation of the shaft means 3 may thusbe fixed relative to the stable support by a locking latch 14 or otherconventional mechanism which prevents movement of the upper ball joint13. Either the shaft means 3 or the retractor may contain the lockinglatch 14 surrounding the upper ball joint 13 or any like fixture tofirmly attach the shaft means 3 to a stable support, e.g., an anchorportion 15 extending from the retractor (not shown).

Referring to FIGS. 1B through 1G, the contact members 1 preferably havefriction means associated with their bottom surface 4 such that thecontact members 1 more securely engage the beating heart when astabilizing force is exerted on the shaft means 3. The friction meansare preferably comprised of a textured surface covering the bottomsurface 4 of the contact member 1, and may be comprised of severalbio-compatible substances such as a textured rubber, textured or ridgedaluminum, stainless steel or the like.

The friction means may also be affixed to or comprised of a memberdisposed between the bottom surface 4 of the contact members 1 and thesurface of the beating heart. In these embodiments, the friction meansis provided to facilitate stabilization of the beating heart bymaintaining close and conforming contact between the contact member 1and the beating heart and reducing the amount of force necessary to beapplied to the exterior of the beating heart in order to achievestabilization. Referring to FIGS. 1B and 1D through 1G, any number ofdifferent configurations and may have a textured surface in a diamondplate, granular, nail-bed, anti-skid, open foam, or otherfriction-providing configuration. The geometric configuration of thesurface, having one side affixed to the contact member 1, may be flat,triangular, rectangular, square, or circular. Alternatively, surfacesproviding a functional adhesive may be obtained using hydrogel,fibrogen, collagen, hydroxy epitate, or other biocompatible material andmay be chemically etched, mechanically scored, or electricallyactivated.

Referring to FIG. 2, one practical method for providing the frictionmeans is a separate member affixed to the bottom surface 4 of a contactmember 1 comprising a snap-in member 16 having means 17 for removablyattaching the snap-in member 16 to the bottom surface 4 of the contactmember 1. This removable attachment feature may be readily provided by apost 18 affixed to each snap-in member 16 and which fits engagingly in aport 19 formed in the body of the contact member 1, or by other likeconfiguration. This embodiment offers several advantages indisposability and ease of manufacture, particularly where it isdesirable to provide an adhesive or friction-providing member separatelyto the bottom surface 4 of the contact member 1, and especially wherethe friction or adhesive member is formed of a different material thanthe body of the contact member 1. The bottom surface 4 of the snap-inmember 16 may have any of the configurations described previously (SeeFIGS. 1B and 1D through 1G).

Given the delicacy of the epicardial cardiac tissue, and the desire toavoid the possibility for damaging the heart as it beats throughout thebeating heart bypass procedure, and to avoid the possibility that thestabilizing means might slip, the contact members 1 of the invention maybe provided with a friction-providing and/or cushioning material at thelower or bottom surface 4 of the contact member 1 to cushion the pointwhere the contact member(s) 1 engage the beating heart. For example,FIG. 3 shows an exemplary material 20 comprising a textured soft rubberor fluid-filled member affixed to the bottom or lower surface 4 of thecontact members 1 to prevent damage to the heart tissue, and to minimizeslippage.

As noted above, a fundamental element of the invention is the contactmembers which engage the surface of the beating heart, in someembodiments proximal to the site of the anastomisis, to directly applythe stabilizing force to the beating heart. The actual shape, size,configuration, and relative orientation of the contact members may varywithout departing from the spirit of the invention. Beating heart may beprovided by a solid structure 21, preferably a dense metal, whichprovides an added weight to add to the stabilizing effect achieved bycontacting the beating heart with the stabilizing means of theinvention. This embodiment facilitates motion cancellation andstabilization of the beating heart by adding additional weight directlyat the site where the contact member engages the beating heart, which inthis embodiment is at the site of the anastomosis. As can be seen inFIG. 4B through line IV—IV of FIG. 4A, in this embodiment, two contactmembers 1 a, 1 b engage the beating heart at their lower or bottomsurface 4, have a greater thickness at their outer edges, and have anopening 22 positioned therebetween, and which traverses the entire spacebetween the contact members 1 a, 1 b such that a vessel may bepositioned therebetween.

FIG. 4C shows an integrated apparatus which may advantageously apply thecontact members 1 to the surface of the beating heart by the action of abalance provided by an adjustable weight 24 and counterweight 25 mountedon opposite ends of a shaft 26 mounted on a fulcrum 27 which ispreferably affixed to a stable support such as the operating table or anaccess platform providing retraction during the surgery. By manipulatingthe adjustable weight 24, varying degrees of stabilizing force may beapplied to the beating heart via shaft means 3 and the contact members1. This embodiment provides a continuously variable quantity ofstabilizing force directed downward by the positioning of the weights24, 25 and the rotation of the shaft 26 about the point of the fulcrum27. Thus, in use, the surgeon may rest the contact members 1 on thesurface of the beating heart with a minimal force applied, and by movingthe adjustable weight 24 away from the fulcrum, cause additional forceto be applied, via the shaft means 3, and the contact members 1, to thesurface of the beating heart.

The positioning of the contact members 1 at the surface of the beatingheart to provide the requisite degree of stabilization may be achievedby several techniques designed to apply a mechanical force to thecontact members that rest in a conformingly fashion at the surface ofthe beating heart to substantially arrest the movement in an a traumaticmanner. The device shown in FIG. 5 has a pair of contact members 1 a, 1b disposed in substantially parallel fashion as in the embodimentspreviously described. However, the device has an additional countercontact member 28 that also engages the surface of the beating heart,but does so at a point slightly removed from the point of engagement ofthe other contact members 1 a, 1 b which are preferably located at thesite of the anastomosis. Additionally, the shaft means 3 may be attachedto and be rotatable about a point 29 located between the contact members1 a, 1 b and the counter contact member 28 and preferably at a point onthe connecting shaft 2 that is slightly elevated. The shaft means 3 ispreferably rotatable, for example by virtue of a ball joint 30, aboutthe point 29 of contact thereby permitting the contact members 1 toself-align and engagingly conform to the surface of the beating heart.Moreover, in this embodiment, when a stabilizing force is applied to thesurface of the beating heart, the force directed down the length of theshaft means 3 is not centered over the site of the anastomosis. Thecounter contact member 28 may also be configured to occlude the targetvessel 31. As with the other embodiments disclosed herein, an embodimentof the type of FIG. 5 may be selected by the surgeon depending on theparticular clinical indication, the particular physiology of a givenpatient, and/or the surgical environment dictated by the access methodused to gain access to the beating heart, for example, sternotomy,thoracotomy, or puncture incision.

Thus, different surgical methods of access, different target vessels,and the anatomical differences between individual patients, may dictatethe use of alternate embodiments of the invention, typically at thediscretion of the surgeon. For this reason, contact members which arecontinuously adjustable, may be particularly preferred for some clinicalindications. For example, FIGS. 6A and 6B show an embodiment of theinvention having a plurality of particles or beads 32 disposed within asubstantially flexible tubular structure or structures 33, and which mayhave a vacuum lumen (not shown) located therein, to provide a contactmeans 1 whose shape and position is adjustable. Preferably, the flexibletube structure 33 has a malleable member 34 such as a wire disposedalong the length thereof to provide a structural memory function andadditional tensile strength. In the embodiment of FIG. 6A, the flexibletube 33 is a single unitary structure which can be bent, typically in aU-shape configuration, to engage the surface of the heart and may haveplurality of discs 35 disposed along the malleable member 34. Also, asillustrated by FIG. 6B, the stabilizing means may be provided by aplurality of contact members 1 a, 1 b as otherwise described herein. Aswith the single unitary structure of FIG. 6A, the plurality of theflexible contact members 1 a, 1 b may be provided with a plurality ofbeads or particles 32 disposed therein and may additionally have theability to be inflated selectively, or selectively deflated, to adjustor fix the position of the contact members 1. When suction is appliedvia the suction lumen, the particles 32 are compressed by atmosphericpressure causing the tubular structure 33 to become rigid, therebyfixing the information of the contact members 1.

As with the embodiments described above, adjustable placement of thecontact members may be particularly useful in a minimally invasiveprocedure. Contact members that releasably contact or are releasablyattached to a shaft may be deployed by separate insertion of the contactmember, and a shaft or shafts which may be independently introduced,manipulated, and withdrawn to provide a stabilizing device held in placeby pressure exerted on the shafts while the anastomosis procedure isperformed at which time the contact members and shafts are removed in anatraumatic manner. Referring to FIGS. 7A and 7B, a unitary contactmember 1 has a plurality of recessed ports 36 adapted to receive thedistal end 37 of a shaft means 3, wherein the distal end 37 is shaped tofit conformingly within the recessed port 36 and wherein the shaft means3 may be removably attached to the contact member 1. As seen in FIG. 7B,this embodiment provides the advantage that the shaft means 3 may beintroduced through a plurality of very small incisions such that severalshaft means 3 may removably engage the contact member 1 at the severalpoints about the periphery of the contact member 1 where the recessedports 36 are formed in the contact member 1 and receive the distal end37 of a plurality of shaft means 3.

FIG. 7C illustrates a separate removable shaft means 3 a that may beutilized with any of the embodiments of the contact members 1 previouslydescribed. In FIG. 7C, the separate shaft means 3 a is separatelyintroduced and has a pair of distal ends 37 that engage equivalentlyoriented and spaced ports 36 found in the contact member 1 to provide anadditional positioning and stabilizing capability by manipulating theseparate shaft means 3 a when the distal ends 37 engage the ports 36.

FIG. 7D is a simplified use of separate shaft means 3 a having anintegral contact member 1 formed from the distal portion 38 of theseparate shaft means 3 a. In this embodiment, the separate shaft means 3a are separately introduced into the surgical field through minimallyinvasive puncture incisions and are separately positioned to bring thedistal portion 38 of each of the separate shaft 3 a to contact thesurface of the heart. Referring to FIG. 7E, the separate shafts 3 a maybe joined at the most distal tip by a discrete interconnecting member 39having openings 40 configured to receive the most distal tip 37 of bothof the separate shaft means 3 a.

FIG. 8 is an additional embodiment of the contact members 1 of theinvention generally comprised of an annular structure 41 which isrotatable relative to the shaft means 3 which is attached at a pointabout the periphery of the contact member 1. In this embodiment, aportion of the bottom surface 4 of the annular portion 41 contacts thebeating heart at a site proximate to the target site for theanastomosis. The annular portion 41 of the contact member 1 may beprovided with a lockable fixture 42 which engages the distal end of theshaft 43, where the shaft means 3 contacts the annular structure 41, tolock the shaft in place. Alternatively, the shaft means 3 may rotatefreely about the periphery of the annular portion 41 of the contactmember 1. Preferably, a portion of the annular contact member 41 has apassage 44 formed through the bottom surface 4 of the annular contactmember 41 where the target vessel 45 passes beneath the annular contactmember 41. Additionally, the annular contact member 41 may havesubstantially planar surfaces 46 which are generally co-planar with thebottom surface 4 of the annular contact member 41 and have a rectangularopening therein for access to the target vessel 45. Planar surfaces 46may assist in providing stabilization at the tissue proximate to theanastomosis, and which also assist in positioning the target vessel 45relative to the annular contact member 41.

The contact members of the invention may also be provided with otherrelated apparatus or fixtures that are commonly used in traditionalsurgical procedures. Such structures or fixtures may be operablyassociated with the body of the shaft means 3, the interconnecting shaft2, or the contact members 1.

Referring to FIGS. 9A through 9E, a suction (negative) pressure or ablower (positive) pressure is useful to maintain a clear and dryanastomosis site. The positive or negative pressure may be provided tothe contact member by a plurality of ports 47 formed in the body of thecontact member. Each port is in pneumatic communication with a lumen 48that is in turn connected to a suction or positive pressure source.Thus, by exerting either a positive or negative pressure on lumen 48,the suction or positive pressure is applied to the site of theanastomosis via ports 47. In FIG. 9A, the ports 47 are disposed in thetop surface of the contact members 1 and have aligned openings in thedirection of the anastomosis site.

As shown in FIG. 9B, the plurality of ports 47 may be provided in adiscreet lumen 48 which is affixed to, and runs longitudinally along,the length of the contact member 1. In this configuration, the pluralityof ports 47 are preferably disposed in a linear configuration along onesurface of lumen 48 to provide negative suction pressure or a positiveflow of pressure about the surface of the contact member 1.

Referring to FIG. 9C, as mentioned above, the plurality of ports 47 andthe lumen 48 may be provided in a manifold-like fashion wherein theopenings of the plurality of ports 47 are formed in the body of thecontact member 1, as is the lumen 48 which is in communication with eachport 47. As an alternate to the plurality of ports 47, a single slot maybe formed from the lumen 48, such that the slot runs along the greaterlength of the contact member 1 as shown in FIG. 9D.

Referring to FIG. 9E, in a variation on the embodiment of FIG. 9B, thelumen 48 may be provided as a malleable tube which is separable from thecontact member 1 along at least a malleable portion 49 of said lumen 48.In this configuration, by manipulating the malleable tube portion 49 oflumen 48, port(s) 47 may be selectively positioned at any pointproximate to the contact member 1.

Referring to FIG. 9F, a manifold similar to that shown in FIG. 9C, maybe provided within the body of the contact member 1 in a configurationwherein the ports 47 are more closely associated with theinterconnecting shaft 2 or the shaft means 3. As in the embodiment ofFIG. 9C, the ports 47 are in communication with a lumen 48 that runs thelength of the shaft means 3 terminating in the plurality of ports 47. Asshown in FIG. 9F, the plurality of ports 47 may apply the positive ornegative pressure from the portion of the interconnecting shaft 2 thatjoins the individual contact members 1.

Referring now to FIG. 9G, as in FIG. 9E, a lumen 48 having a malleableportion 49 may be provided for selective positioning of a positive ornegative pressure which may be applied at any point proximate to thestabilizing means of the invention by manipulating the position of themalleable portion 49 of the lumen 48 to selectively position port 47.

In a similar structural configuration to FIGS. 9A through 9G, FIG. 9Hsupplies an incandescent or fiber optic light source 48 a proximate tothe contact members 1 by placing the light source within the shaft means3 to have an opening or lens to provide light at the site of thestabilization.

An additional conventional surgical apparatus which may beadvantageously applied to the stabilizing means of the present inventionis a selectively positionable surgical drape that assists in providing adry and sterile field, and which assists the surgeon during theprocedure by visually isolating the site of the anastomosis. FIG. 10Ashows a retractable and extendable drape 50 surrounding shaft means 3.In the retracted configuration 51, shown in phantom in FIG. 10A, theretractable drape is closely conformed to the shaft means 3 to beunobtrusive. The drape 50 may be affixed to the shaft means 3 by awasher element 52 that is directed downward to deploy the drape 50. Whenthe washer element 52 reaches the maximum downward position, theretractable drape 50 is doubled over to form a portion of a circularcovering surrounding the surgical site and generally opposite the areawhere the contact members 1 abut the surface of the beating heart. Anadditional embodiment, shown in FIG. 10B, has a surgical drape 50affixed to the outer portion of each contact member 1 a, 1 b. While thisconfiguration is not retractable, surgical drapes 50 as shown in FIG.10B may be provided with structural support members 53 that providetensile strength and shape to the surgical drape 50 and which mayprovide supplemental stabilizing force by contacting the beating heartabout the periphery of the contact members 1 a, 1 b An additionalconfiguration for surgical drapes 50 affixed to contact members 1 isshown in FIG. 10C where a plurality of drape supports protrude radiallyfrom several points about the periphery of the contact members 1 a, 1 band terminate in drape fastening means 54 a at their most distalportion. A portion of the drape 50 is attached to each drape fasteningmeans 54 a to spread the drape over the surgical site and may providecoverage extending in all directions outward from the contact members 1.

Referring to FIG. 11, a mechanical fixture to facilitate completing theanastomosis may be directly attached to the contact member 1. A separatedevice to facilitate completing the anastomosis is generally comprisedof a hinged or rotatable vessel support member.55 that permits selectivepositioning of the source vessel, such as the distal end of an internalmammary archery or the distal end of a venous or arterial graft,proximate to the target vessel 56. The vessel support member 55 isoriented on the contact member 1 such that the vessel source broughtinto direct alignment with an arteriotomy formed in the target vessel56, which is disposed between the contact members 1. To facilitate thecompletion of the anastomosis, a vessel receiving member 57 is closelyassociated with the contact members 1 and generally surrounds thearteriotomy in the target vessel 56. The vessel support member 55 has ananastomosis coupling fixture 58 that is attached to the distal end ofthe source vessel and is shaped to be brought into engagement with thevessel receiving member 57. The anastomosis coupling fixture 58 isattached to the periphery of the IMA or graft such that when the vesselsupport member 55 is positioned proximate to the arteriotomy, the vesselreceiving member 57 and the anastomosis coupling fixture 58 are broughtinto alignment such that a fluid communication between the source vessel59 and the target vessel 56 is established upon completion of theanastomosis. Completion of the anastomoses is facilitated by anautomatic suturing securing mechanism 60 or other like apparatus fortightening the sutures to join the two vessels. Preferably, the vesselreceiving member 57 and the anastomosis coupling fixture 58 are operablyassociated with a plurality of sutures 61 which penetrate the peripheryof the arteriotomy formed in target vessel 56 and connect the peripheryof target vessel 56 to the periphery of the source vessel 59. Thus,while simultaneously actuating the vessel support member 55, theautomatic suturing device 60 brings the vessels into close conformityand completes the anastomosis procedure to establish fluid communicationbetween the source vessel 59 and the target vessel 56.

Referring to FIG. 12, a separate member for conveniently holding thesource vessel may be provided without a dedicated apparatus forcompleting the anastomosis. A malleable wire 62 is operably affixed tothe shaft means 3 or to the contact member (not shown) and has a sourcevessel holder 63 such that the source vessel 64 may be prepared andconveniently held at a point away from the target vessel 56 until thesurgeon is prepared to complete the anastomosis. Preferably, the sourcevessel holder means 63 is comprised of a clamp for gripping andmaintaining the source vessel 64 in a preferred configuration prior tocompleting the anastomosis, such as by separating or spreading thetissue attached to the most distal portion of the source vessel 64 tomaintain the integrity and patency of the distal end of the sourcevessel 64.

As mentioned above, it is particularly preferred that the instruments ofthe invention be used in a minimally invasive bypass graft procedurewherein a minimal thoracotomy provides access to the beating heart. Aminimal thoracotomy is a small surgical opening provided between theribs and is formed, to the extent possible, proximate to the targetartery of the beating heart where the anastomosis is to be formed. Toprovide access to the beating heart via the minimal thoracotomy, thecannula may be disposed between the ribs to provide access to thebeating heart. Referring to FIGS. 13A through 13E, alternateconfigurations for a cannula disposed between adjacent ribs are shown.The embodiment of FIG. 13A has a cannula support bracket 67 having aplurality of holes through which screws 66 may pass to provide means toattach the assembly to the chest such as by placing the screws inadjacent ribs 69 a, 69 b. The cannula receiving assembly 67 may have oneslot 65 formed therein such that one of the screws 66 may slide thereinfor spreading the adjacent ribs 69 a, 69 b apart. The cannula receivingassembly 67 provides an opening between adjacent ribs 69 a and 69 b suchthat the cannula 68 may be passed therethrough. Referring to FIG. 13B,in an alternate embodiment, the cannula receiving assembly 67 isreplaced by a cannula 68 surrounded by a large thread means 70. Thedistal end 71 of the cannula 68 may be inserted between the ribs androtated such that the thread means 70 cause cannula 68 to be advancedbetween the adjoining ribs 69 a, 69 b, and by virtue of the expandingdiameter of the thread means 70, to spread adjoining ribs 69 a, 69 bapart while positioning the cannula 68 therebetween. In yet a furtherembodiment, in FIG. 13C, a cannula assembly 75 is provided having a clawmechanism comprised of opposing blades 73 and interlocking member 72.Adjacent ribs 69 a, 69 b are engaged by opposing blades 73, and, byforcing the cannula 68 downward, the opposing blades 73 rotate outwardsuntil a locking member 72 fixes the position of the opposing blades 73in a locked and opposing relationship as shown in FIGS. 13D and 13E.Thus, by forcing cannula 68 downward, adjacent ribs 69 a and 69 b arespread apart by opposing blades 73 and the cannula assembly 75 is fixedin position by locking member 72 such that cannula 68 is positioned toprovide access to the beating heart.

A modified large diameter cannula having an extended vertical height,may perform several functions in a minimally invasive CABG procedure.For example, referring to FIG. 14, an enlarged cannula 74 may beprovided in the shape of an inverted cone structure having an enlargedproximal opening 76 with an enlarged diameter, and a distal opening 75having a reduced diameter and where said distal opening 75 abuts thesurface of said beating heart. By exerting a downward force on theinverted, enlarged cannula 74, the inverted conical shape of the cannula74 forcibly spreads adjacent ribs 69 a, 69 b, and provides a stabilizingforce when the distal portion 75 contacts the surface of the beatingheart. Surgical access to the stabilized heart is provided throughenlarged proximal opening 76.

FIGS. 15A and 15B show an embodiment of the invention in use with aconventional cannula. In FIG. 15A, a conventional cannula 77 is insertedthrough a puncture incision in chest wall 80. The distal end of thestabilizing means 78 (similar to FIGS. 31A and 31B below), is introducedin a contracted configuration through the cannula 77 to bring the distalend thereof in contact with the surface of the beating heart 79.Referring to FIG. 15B, the stabilizing means of the invention are fullyinserted through the cannula 77 and manipulated to bring the contactmembers 1 into contact with the surface of the beating heart 79. Bymanipulating handles 81 of the stabilizing means, the contact members 1are spread apart at the surface of the beating heart to provide thestabilizing function during the surgical procedure.

Where a minimally invasive procedure is employed, the means forstabilizing the beating heart of the invention are preferably providedin an embodiment where the contact members 1 that engage the surface ofthe beating heart are inserted and withdrawn from the surgical field ina position or a configuration having a reduced dimensional profile,i.e., a reduced effective diameter when inserted and removed from thethoracic cavity. For example, these embodiments are particularly usefulwhen the surgery is performed through a plurality of puncture incisions.

In the embodiment of FIGS. 16A through 16E, a pair of rectangular, andsubstantially planar contact members 1 a, 1 b are disposed within agenerally cylindrical main shaft 82. In the retracted configurationshown in FIG. 16A, each contact member 1 a, 1 b is rolled into acollapsed, annular configuration to reduce the effective diameter of thedevice by having the contact members 1 a, 1 b maintained within theshaft 82 when the device is inserted through an incision. In thisconfiguration, each contact member 1 a, 1 b is attached to a centralshaft 83 by a connecting shaft 2 which has a tensioning wire 84 orspring mounted to the connecting shaft 2 and the central shaft 83 todeploy each contact member 1 a, 1 b when the central shaft 83 isextended from the substantially cylindrical main shaft 82 in which thecontact members 1 a, 1 b are originally retained. Thus, in use, thecontact members 1 a, 1 b are maintained in the retracted annularconfiguration of FIG. 16A until deployed within the surgical field asshown in FIGS. 16B through 16E, by extending the central shaft 83downward causing the contact members 1 a, 1 b to be deployed below themain shaft 82. The contact members 1 a, 1 b unfold from their annularconfiguration and deploy into their substantially planar shape as shownin FIG. 16C. The contact members 1 a, 1 b rotate into position relativeto the central shaft 83 by the tension in wire or spring 84 which ispreferably disposed to act upon the connecting shaft 2 to cause contactmembers 1 a, 1 b to be fixed in a substantially parallel position to oneanother and substantially co-planar with the surface of the beatingheart as shown in FIGS. 16D and 16E.

Thus, FIG. 16A shows the contact members 1 a, 1 b in their collapsed orretracted position. FIG. 16B shows the contact members in the process ofbeing deployed as the central shaft 83 is extended from the bottom ofthe main shaft 82. FIGS. 16D and 16E show the tensioning wire 84 forrepositioning the contact members 1 a, 1 b in the desired position foruse in surgery. FIG. 16C shows the central shaft 83 fully extended fromthe bottom of the body of the main shaft 82 causing the deployment ofthe contact members 1 a, 1 b into the desired configuration forstabilizing the beating heart.

Preferably, the connecting shaft 2 joining the individual contactmembers 1 a, 1 b is hinged 85, such that upon completion of theanastomosis, the contact members 1 a, 1 b may be withdrawn by pullingthe central shaft 83 upward relative to the main shaft 82 and into thebody of the device, thereby causing the contact members 1 a, 1 b to beremovable in a low-profile configuration.

Referring to FIGS. 17A through 17D, a similar strategy as is shown inFIGS. 16A through 16E is used whereby a pair of contact members 1 a, 1 bare deployed by a main shaft 86 within a hollow portion of the body 87of the device. In the embodiment shown in FIGS. 17A through 17D, a pairof non-flexible contact members 1 a, 1 b may be provided to stabilizethe beating heart in a minimally invasive environment by containing thecontact members 1 a, 1 b in a body or housing 87 which is insertedthrough the minimally invasive incision. In this embodiment, the contactmembers 1 a, 1 b are mounted to a central shaft 86 by virtue of a pin orhinge 88 which affixes the end of the contact members 1 a, 1 b to thecentral shaft 86 such that the contact members 1 a, 1 b may be deployedby rotating around the pin or hinge 88 when the shaft 86 is extendeddownward from the body 87 of the device. The opposite portion of thecontact members 1 a, 1 b (most distal from the hinge) may fit within aguide fixture 89 concentrically associated with the central shaft 86that retains the contact members 1 a, 1 b in the desired configurationprior to deployment. In use, the central shaft 86 telescopes from anopening in the distal end of the body or housing 87 of the device by adistance at least as great as the overall length of the contact members1 a, 1 b, at which point the contact members 1 a, 1 b may be deployedand locked into position, for example, in an orientation substantiallyperpendicular to the shaft as shown in FIGS. 17A and 17C. Once fixed inposition by locking mechanism 90 as shown in FIG. 17C, the central shaft86 may be rotated using the guide fixture 89 which is positioneddownward to engage the contact members 1 a, 1 b Thus, the guide fixture89 engages the contact members 1 a, 1 b, the pin 88, or the lockingmechanism 90, and by applying mechanical force, the position of thecontact members 1 a, 1 b may be adjusted. Upon removal, the centralshaft 86 is withdrawn into the body 87 of the device. Alternatively, thehousing 87 may disengage the locking mechanism 90 from the guide fixture89 releasing the position of the contact members 1 a, 1 b therebyallowing the contact members 1 a, 1 b to be returned to their originalor other configuration that allows the contact members 1 a, 1 b to bedrawn into the body of the device 87 to facilitate minimally invasiveremoval thereof.

FIGS. 18A through 18D are an analagous embodiment having contact members1 a, 1 b retained in the undeployed configuration suitable for insertionthrough a minimally invasive incision. As shown in FIGS. 18A and 18B,the contact members 1 a, 1 b may be maintained in a retracted positionsuch that the length of the contact members 1 a, 1 b is substantiallyparallel to the central shaft 92. The proximal end of each contactmember 1 a, 1 b is affixed to the guide fixture 93 while the distal end(below the hinge at central portion 91) has the bottom surface 4 formedtherein and is affixed to the distal end of the central shaft 92.Referring to FIG. 18C, the contact members 1 a, 1 b are deployed by thedownward motion of the guide fixture 93, such that the contact members 1a, 1 b fold about the central portion 91. When the guide fixture 93 isfully extended downward, the contact members 1 a, 1 b are formed of apair of two-part structures wherein the lower structure contains thebottom surface 4.

FIGS. 19A and 19B are an additional embodiment having foldable contactmembers 1 a, 1 b wherein a central shaft 94 is affixed to a plurality ofhinged struts 95 that are connected to opposite ends of contact members1 a, 1 b about a hinged central portion 96. When the central shaft 94 isextended downward, the hinged struts 95 deploy outward. As shown in FIG.19A, the individual contact members 1 a, 1 b fold at the central hingedportion 96 to reduce the overall dimensional profile of the device forminimally invasive insertion or removal. When fully deployed (FIG. 19B),the contact members 1 a, 1 b are extendable to a substantially planarconfiguration as with other embodiments disclosed herein.

FIGS. 20A through 20E show the central shaft 97 and contact members 1 a,1 b with alternate configurations for positioning the contact membersfor minimally invasive insertion and removal. Referring to FIG. 20A,first hinges 98 are provided in the connecting shaft 2 such that thecontact members 1 a, 1 b can be rotated approximately 90° out of theirco-planar configuration. A second hinge 99 is provided between the shaftmeans 3 and the connecting shaft 2 to tilt the distal end of the contactmembers 1 a, 1 b downwards as shown in FIG. 20C. The embodiments ofFIGS. 20D and 20E are modified such that two interconnecting shafts 2 a,2 b maintain the contact members 1 a, 1 b in slightly separate, yetparallel, vertical positions. A single hinge 100 with a vertical axis ofrotation allows the contact members to be brought into close conformitybefore being tilted downward.

FIGS. 21A through 21C show a deployable stabilizer of the inventionhaving contact members comprised of a single continuous wire 101 that isdeployable from within a housing or body 102 which is ideally insertedthrough a minimally invasive incision. As shown in FIG. 21A, the singlecontinuous wire 101 may be coiled and contained within the housing 102such that the dimensional profile of the stabilizer is minimized forinsertion. The wire 101 which forms the contact member(s) of thisembodiment is preferably round and smooth, and may be formed of amaterial such as Nitinol that is collapsible, and deployable into apredetermined shape. As can be seen in FIG. 21B, following insertion,the wire 101 is extended from the body 102 of the device to form atleast one loop 103 wherein at least one side 104 of the loop 103contacts the surface of the heart. Preferably, at least two loops 103extend from the body 102 of the device and are formed from a single wire101. In this configuration, maximum stabilization is achieved ifsubstantial portions of the sides 104 of both loops 103 contact thebeating heart proximate to the target vessel. As in the previousembodiments, the insertion and removal of the stabilizing device througha very small incision is least traumatic when the dimensional profile,or effective diameter, of the contact members in a retractedconfiguration is not substantially greater than the dimensional profileor diameter of the body 102 of the device. Thus, as can be seen in FIG.21C, the contact members of the embodiment of FIGS. 21A through 21C aredrawn upward by exerting force on the wire 101, the contact memberscomprised of loops 103 are drawn into a configuration which is inalignment with the body 102 of the device such that their removal may beachieved through a puncture incision with minimal additional trauma tothe patient.

In addition to a single continuous wire 101, the contact members may beformed of a helical wire coil 105 as shown in FIGS. 22A through 22C. Asin the embodiments described previously, the contact members 1 a, 1 bare deployed by extending a tubular central shaft 106 through a body orhousing 107 of the device to deploy the contact members 1 a, 1 b Thedownward motion of the central shaft 106 is terminated by the contactbetween a stop 109 and the distal end of the body 107. The contactmembers 1 a, 1 b are withdrawn into the body 107 of the device uponcompletion of the surgical procedure by pulling the central shaft 106vertically through the body 107 of the device. A predetermined curve inthe helical coil 105 may be provided by spacing members 108 placedbetween adjacent individual loops 105 a and 105 b of the helical coil105. The central locking wires or cables may be tensioned upondeployment to increase the rigidity of the structure.

An additional configuration for minimally invasive insertion and removalis shown in FIGS. 23A and 23B wherein the contact members 1 a, 1 b areformed of an inflatable balloon 110 that is pre-shaped to provide anydesired configuration of the contact members 1 a, 1 b FIG. 23A shows apre-formed inflatable balloon 110 in an inflated state and extended fromthe housing 111. Inflation is achieved by a central lumen 112 disposedwithin the central shaft 111. FIG. 23B shows the inflatable balloon 111in an uninflated state for insertion or for removal.

Referring to FIGS. 24A and 24B, an inflatable contact member may also beprovided by a cuff 113 which is positioned such that the circumferenceof the cuff 113 contacts the beating heart about its periphery.Preferably, the target vessel 114 is positioned to bisect an annularcuff 113 to provide maximum stabilization. Additionally, referring toFIG. 24B, separate contact members 1 a, 1 b, as previously describedherein, may be integrally formed with the cuff 113 by mounting thecontact members 1 a, 1 b in the wall of the cuff 113 to extend into theinterior thereof.

FIGS. 25A and 25B illustrate an embodiment of the invention whichprovides minimal trauma to the patient during insertion and removal ofthe stabilizing means by containing a simple stabilizer in an instrumenthaving a housing 115 with an extremely limited cross-section such thatthe instrument can be inserted through an extremely small incision. Inthis embodiment, the entire stabilizing means is contained within thehollow housing 115 and is comprised of a pair of contact members 1 a, 1b which are joined at the most distal end thereof. As can be seen inFIG. 25B, the contact members 1 a, 1 b are formed from a unitary shaft116 having a divided portion 117 at the distal end such that upondeployment from the housing 115 of the device, the divided portion 117splits into two contact members 1 a, 1 b joined at their most distal tip118 and which may be brought into contact with the beating heart alongthe divided portion 117 of the unitary shaft 116.

In addition to the friction means or cushioning members described abovein FIGS. 1B through 1G and FIG. 3, sutures may be used to attach orposition epicardial tissue relative to a contact member 1 to enhance thestabilization function of the invention and to position epicardialtissue or the target vessel of the anastomosis. FIGS. 26A, 26B, and 26Care embodiments where means for fixing the position of epicardial tissueis comprised of sutures 119 used in combination with the contact members1 a, 1 b to stabilize and position tissue surrounding the site of ananastomosis and the target cardiac artery. In FIG. 26A, a series ofsutures 119 is placed through the epicardial tissue (not shown) andlooped around the contact members 1 a, 1 b to effectively positionseveral points on the surface of the beating heart in fixed relationshipto the contact members 1 a, 1 b In FIG. 26B, the contact members 1 a, 1b and optionally the shaft means 3 associated therewith have passages120 formed therein through which a suture line 119 may be passed. In theparticular example of FIG. 26B, a single suture 119 is passed throughthe body of the shaft 3, exits from within the first contact member 1 athrough a passage 120 formed therein, passes underneath the targetvessel 121, emerges from an opposite side of the target vessel 121, andenters a passage 120 in the opposite contact member 1 b joined to thefirst contact member 1 a by the connecting shaft 2. The suture 119 exitsthe opposite contact member 1 b again passes beneath the target vessel121, reenters the first contact member 1 a at a separate passage 120,and passes through the body of the first contact member 1 a and into theshaft means 3. In this configuration, the suture lines may bemanipulated by the surgeon from a remote location, such as external tothe incision in the chest, to remotely position the vessel by drawingtension on the suture line 119. FIG. 26C shows a similar arrangement forthe suture line 119 as in FIG. 26B, however in FIG. 26C, apertures 122in the body of contact member 1 are used to select the direction of thesuture 119 rather than having passages 120 which traverse the body ofthe contact member 1. Also, in this or the other embodiments, a separatesliding shaft 123 may be provided that gathers and is traversed by thesutures 119. The step of drawing tension on the suture line 119 isfacilitated by advancing the sliding shaft 123 to abut the contactmember 1 and exerting a small downward force on the sliding shaft 123while exerting an upward force to draw tension on the suture line(s)119. By maintaining downward force on the sliding shaft 123, the targetvessel 121 is raised while the potential for displacing the contactmember 1 is minimized because the upward force exerted on the suturelines 119 is countered by the downward force exerted on the slidingshaft 123.

Referring to FIGS. 27A and 27B, a modification of the contact member 1of the invention may be provided by a structure formed at the distal endof the shaft means 3 and which is inserted directly into the arteriotomy124 formed in the target vessel. This intravessel stabilizer 126 has abody designed to fit conformingly about the interior of the targetvessel, and may be in communication (including fluid communication) witha hollow portion of the shaft means 3. The body 126 of the intravesselstabilizing means may be a substantially cylindrical lumen as shown inFIG. 27B and should have an overall length which is greater than thelength of the incision creating the arteriotomy 125. Additionally, inthe embodiment of FIG. 27B, the intravessel stabilizer 126 may beperpendicular to the shaft means 3 and have cuffs 127 at the distal endof the body 126 to provide conforming engagement with the interior ofthe target vessel. As shown in both FIGS. 27A and 27B, this embodimentof the stabilizing means of the invention is preferably used inconnection with a plurality of sutures 128 that penetrate the edges ofthe target vessel about the circumference of the arteriotomy 125. Byexerting pressure on the shaft means 3 and the plurality of sutures 128,the target vessel is stabilized, and its position may be manipulated, tofacilitate completion of the anastomosis.

In addition to stabilization of the beating heart proximate to thetarget vessel of the anastomosis, additional fixtures, structures orelements associated with the contact members 1 can be used to retract orfix epicardial tissue proximate to the target vessel and the site of theanastomosis by using a means for gripping epicardial tissue at thesurface of the exterior of the heart. The means for gripping may beprovided by several different embodiments. For example, FIG. 28A shows afunctional clamp 128 formed by a crimping contact member 1 that has afold 129 disposed longitudinally at the center of the length of thecontact member 1. When force is applied to the sides of the contactmember 1 opposite the fold 129, the crimping action of the contactmember 1 grasps the epicardial tissue 130 at the heart surface 131 andcontains it within the folded contact member 132. In another embodiment,as shown in FIG. 28B, a plurality of open passages 133 are provided in acontact member 1 that has a slidable member 134 disposed within a slot135 formed within the contact member 1. When sufficient force is exertedin a downward direction on shaft 3 to force epicardial tissue 130through-the open passages 133, the slidable member 134 then may beactuated to grip the tissue 130 contained within the open passages 133.By gripping a portion of epicardial tissue 130, the tissue may be spreadto more readily expose the target vessel 136 of the anastomosis.

A similar function is provided by a pair of contact members 1 that areformed of circular rollers 137 that lie longitudinally parallel to thedirection of the target vessel 136 as shown in FIGS. 29A and 29B. Thecontact members 1 may be comprised of movable rollers 137, belts, orpivoting surfaces that may be rotated independently about an axis 138dedicated to each contact member 1 such that the epicardial tissue 130is gathered or spread, depending on the respective directions ofrotation of the rollers 137, as desired at the surface of the heart toexpose the target vessel 136. As will be apparent to those skilled inthe art, each of these embodiments may be provided with contact members1 that are independently movable in a parallel, V-shaped, or otheradjustable configuration as described and illustrated herein.

Referring to FIG. 30, the contact members 1 may be further comprised ofa spring-tensioned frame 139 having a movable frame extension 140 whichmay have pins or an associated friction means 4 at the bottom surface 4of the contact members 1 a, 1 b to engage the tissue proximate to thetarget artery. The movement of the frame extension 140 is tensioned by aspring means 141 which draws the frame extension 140 toward the contactmember 1 after the frame extension 140 has been manually positioned toengage the tissue. The use of this embodiment of the invention is thesame as is described for the other embodiments herein, with the frameextension 140 providing the improved exposure of the target artery byretraction of the epicardial tissue. As with the other embodiments, thecontact members 1 may be attached at one end by a connecting shaft 2which is attached to a shaft means 3 as described above. The connectingshafts 2 may also be positioned relative to one another by aconventional threaded post 142 with a positioning thumbscrew 143.

Referring to FIGS. 31A and 31B, the stabilizer means may also becomprised of a single shaft means 3 connected to each contact member 1.In a preferred embodiments the shaft means 3 are interconnected at anintermediate pivot point 144 which permits the contact members 1 to becontinuously positioned in parallel fashion relative to one another. Theproximal (upper) portion of the individual shaft means 3 may have gripsadapted to be grasped by the hand or may have an anchor portion 145 forattachment to a retractor or other fixed support. As with the otherembodiments described herein, the length of the shaft means 3 may beadjustable by a conventional telescope configuration. In such aconfiguration, a first shaft 148 has a partially hollow segment 147adapted to receive the complimentary portion of the second shaft 148.Either first 146 or second 148 shafts may be connected to the contactmembers 1 and may each have a conventional interlocking mechanism 151 tofix the relative positions of the shafts. The shaft means 3 may alsohave a tensioning spring mechanism 150 having an axis 149 which isdisplaced between a portion of the shaft means 3 affixed to the contactmembers 1 and the remainder of the shaft means 3. In this configuration,the contact members 1 remain tensioned against the heart proximate tothe anastomosis site when the proximal end of the shaft means 3 isaffixed to a stable support. This embodiment also preferably has afriction means as described above affixed to the bottom surface 4 ofeach contact member 1. An additional advantage of this embodiment isderived from the capability to move the contact members 1 apart from oneanother in a parallel configuration. Thus, the contact members 1 canfirst be positioned to engage the surface of the heart tissue, followedby the application of a stabilizing force in combination with spreadingor joining of the proximal (upper) end of the shaft means 3. Applicationof a stabilizing force causes the tissue on either side of the targetartery to be spread or compressed while the heart is stabilized. Thus,by coincidentally spreading or joining the proximal portion of the shaftmeans 3, the epicardial tissue engaged by the contact members 1 isstretched or compressed to provide stabilization and improved exposureand positioning of the target coronary artery.

Referring to FIGS. 32A through 32C, the contact members 1 may haveassociated therewith additional structures which serve to position orretract epicardial tissue, at or around the surface of the heart,particularly tissue in the vicinity of the site of the anastomosis.Often, the surgeon wishes to retract the epicardial tissue near thetarget vessel to increase exposure of the vessel where the anastomosisis to be performed. Additionally, these associated structures provide anadditional amount of stabilization by actually penetrating the tissue atthe outer layer of the heart and holding the tissue in close conformityto the contact member.

Referring to FIG. 32A, epicardial tissue retractors are provided by aseries of curved pins 152 which generally extend from one contact member1 a to the other 1 b by virtue of a guide 153 attached to the bottom ofeach contact member 1 and which is dedicated to a single pin 152. Inthis embodiment, a plurality of pins 152 are substantially parallel toone another and may be inserted and positioned to pass beneath thevessel where the anastomosis is to be performed. In this fashion, thesurgeon can position the vessel, by virtue of the tissue engaged by thepins 152 and the contact members 1 a, 1 b in any direction. Thisembodiment is particularly useful to vertically displace the tissue,i.e., in a direction perpendicular to the shaft means 3.

An additional embodiment is shown in FIG. 32B, whereby a plurality ofshort pins 154 extend down from the bottom surface 4 of the contactmember 1 to enter the epicardial tissue. The short pins 154 may extendin a direction substantially perpendicular to the surface of the tissueand the bottom surface 4 of the contact member 1, or may be angledoutward to engage the tissue. The advantages of this embodiment are bestutilized with a stabilizing means wherein the individual contact members1 a, 1 b may be selectively positioned such that the distance betweenthe individual contact members is varied. Thus, the contact members 1 a,1 b can be brought into contact with the surface of the beating heartfollowed by spreading the contact members 1 a, 1 b apart from oneanother to provide retraction and spreading of the epicardial tissue.This is readily achieved in the embodiment of FIG. 32B, wherein a singleshaft means is dedicated to each contact member 1 a, 1 b, respectivelyand the individual shafts are joined by an intermediate pivot point 155.

A similar embodiment is shown in FIG. 32C, however, in this embodiment,while each contact member 1 a, 1 b has a dedicated shaft, the shaft 156dedicated to the first contact member la is disposed within a hollowshaft 157 dedicated to the second contact member 1 b In thisconfiguration, each shaft 156, 157 may be individually rotated about theother to provide a V-shaped retraction of the epicardial tissue. In thisembodiment, the epicardial retractor pins 154 are preferably similar instructure and orientation to the embodiment of FIG. 32B. The pins inboth designs could alternatively be curved or angled inward, and thecontrast members 1 moved toward each other, providing a compression ofthe epicardium to stabilize the tissue and present the anastomosis siteto best advantage. This action may also serve to occlude the blood flowin the coronary artery, minimizing blood loss and obstructions of thevisual field.

Referring to FIGS. 33A and 33B, the stabilizer means may comprise atleast one stabilizer plate which is attached to a stable support by theshaft means 3 and which may be used with a lever member 158 forimproving exposure at the target artery while the anastomosis iscompleted. In this embodiment, the means for stabilizing the beatingheart comprises a left and right stabilizing plate 159, 160 which areoriented to exert a downward force on the epicardial tissue at eitherside of the target artery at the anastomosis site and which may besubstantially planar or may be curved to conform to the surface of theheart. One or both of the stabilizing plates 159, 160 may have an edge161 deflected downward along its length so that the edge 161 depressesthe tissue proximate to the artery to increase the exposure of theartery during the completion of the anastomosis. Preferably, the edge161 of the stabilizing plates 159, 160 has a separate lever member 158running substantially parallel to the artery and on both sides thereof.The top portion of each lever member 158 contacts the underside of thestabilizing plates 159, 160. In this embodiment, the lever member 158 issubstantially cylindrical, traverses the stabilizing plate along itslength, and is oriented to be parallel to the edge 161 of thestabilizing plate 159, 160. The lever member 158 is fixed in place, andmay be affixed to the heart by a suture. In such a configuration, eachof the stabilizing plates 159, 160, which is in contact with the levermember 158 along its length, contacts the heart such that the edge 161depresses the tissue on both sides of the target coronary to restrictthe movement of the beating heart. The stabilizing plates 159, 160 canbe attached to one another or can move independently as desired.

Opposite the edge 162, at a point separate from the lever member 158,the stabilizing plates 159, 160 are connected to a shaft means 3 whichholds the stabilizing plates 159, 160 in position and which may bemanipulated relative to the lever member 158 to cause the edge 161 toengage the heart. The shaft means 3 is preferably affixed to eachstabilizing plate 159, 160 at a point opposite the edge 161 and removedfrom the point where the lever member 158 contacts the stabilizer plates159, 160 at a location to maximize leverage when the stabilizer plates159, 160 are drawn upwards at the point of attachment of the shaft means3. The shaft means 3 may be constructed as described elsewhere hereinand should be of sufficient length to facilitate manipulation of theshaft means 3 by the surgeon. As noted, the shaft means may also beattached to the retractor to fix movement of the stabilizing plates 159,160 during the procedure.

In a preferred embodiment, the length of the shaft means 3 is adjustablerelative to the retractor or other stable support. For example, theshaft means 3 may be telescopic as described above or may be comprisedof a hollow post 163 which receives a rigid shaft 164 which is in turnfixed to the retractor. The rigid shaft 164 may also be substantiallyhollow and may have a suture or other line 165 passed therethrough andwhich also passes through the length of the hollow post 163. In thisconfiguration, one end of the suture or line 165 is attached to thestabilizing plates 159, 160 and the other end extends through the hollowpost 163 or the rigid shaft 164 to a position where it may bemanipulated by the surgeon. The position of the stabilizing plate 159,160 may thereby be remotely actuated. By drawing tension on the sutureor line 165, the stabilizing plate 159, 160 pivots about the levermember 158 and the edge 62 of the stabilizer plates 159, 160 depress thetissue on either side of the target artery.

Referring to FIGS. 34A through 34E, a lockable mechanism may be providedto depress tissue on either side of a target vessel by a movable edge176 formed along the edge of a block 177 which rotates about a supportmember 178 by means of a hinge pin 179. The support member 178 may beaffixed to the upper surface of a contact member as described herein ormay itself comprise the contact member. In use, as shown in FIG. 34B,the block 177 is rotated about the support member 178 using hinge pin179 until the movable edge 176 contacts the surface of the heartparallel to the target vessel 180 (FIG. 34C). The moveable edge 176 andblock 177 are fixed in place by depressing locking member 181 to forcethe block 177 to rotate until an interconnecting member 182 extends theblock 177 and edge 17 to fully depress the tissue proximate to thetarget vessel 180. At this point, and shown in FIG. 34D, the lockingmember 181 fixes the interconnecting member 182 in an extended positionand is locked in place (FIG. 34E). The position of the block 177 may bereleased by actuating the locking member 181 to release theinterconnecting member 182.

Due to the fact that the heart continues to beat during the CABGprocedures described herein, features of the invention which provide thecapability to manipulate the target vessel, and to control the flow ofblood therein, may greatly facilitate an efficient completion of theanastomosis. For example, additional components associated with thecontact members 1 may be used to occlude the target vessel during theanastomosis procedure. Any of a variety of fixtures may be provided tooperate in association with the contact members of the invention inorder to occlude the vessel that is the target of the anastomosis.

Referring to FIG. 35, a stabilizing means 166 is comprised of a contactmember which is substantially planar and has a substantially rigidsurface 167 having a centrally disposed opening 168 in which the targetartery of the anastomosis is positioned longitudinally through theopening. At either or both ends of the centrally disposed opening 168,an occluder 169 extends below the surface 167 and engages the targetartery to substantially reduce or eliminate the flow of blood throughthe artery. The occluder 169 is a deformable member having a smoothouter surface for adjustably contacting and depressing the target arterywithout damaging the tissue. The planar surface 167 of the stabilizingmeans also has an aperture 170 comprising an opening which traverses theentire planar surface 167 so that the graft can be passed through theaperture 170 when the anastomosis is completed. The planar surface 167may also provide a mounting surface for springed tissue retractors 171comprising a coiled spring 172 attached to the planar surface at one endand having a hook or pin 173 at the opposite end to engage and spreadthe tissue proximate to the anastomosis site to improve the exposure ofthe target artery. The planar surface 167 is attached to a post 174which may be attached to a stable support such as a rib retractor. Theplanar surface 167 may also have at least one port 175 for receiving asuture line.

Referring to FIG. 36, the stabilizing means may have operably associatedtherewith an artery occluder 183, which is preferably attached to thecontact members 1 or to the connecting shaft 2. The artery occluder 183may comprise a semi-rigid member which has a blunt portion 184, whichmay be positioned such that the blunt portion 184 engages the targetartery 185 and compresses the target artery 185 to a point causingocclusion of the target artery 185 passing between the contact members 1such that the blood flow through the artery is substantially reduced oreliminated. Preferably, the occluder 183 has a shaft portion 186 whichtraverses the connecting shaft 2 such that the blunt portion 184 of theoccluder may move from above the level of the target artery 185 to apoint below the level of the original vessel sufficient to occlude theblood flow through the vessel.

Referring to FIG. 37A, a concentrically movable shaft 187 is disposedwithin the shaft means 3 to which the contact members 1 are connected.In this embodiment, the target vessel 188 is positioned directly betweenand parallel to the longitudinal or greater length of the contactmembers 1. When so positioned, the concentric shaft 187 within the mainshaft means 3 may be pressed downward such that the distal end 189 ofthe concentric shaft 187 encounters the vessel 188 and compresses thevessel, thereby occluding the vessel 188 to substantially prevent theflow of blood therethrough. This embodiment has the advantage that theamount of occlusion is continuously variable by varying the forceapplied and the distance by which the concentric shaft 187 is depressedrelative to the shaft means 3. FIG. 37B is a similar embodiment of theinvention whereby a means for occluding the vessel is affixed directlyproximate to the contact members 1. In the example of FIG. 37B, apushbolt 196 is disposed on the connecting shaft 2 that joins opposingcontact members 1 and is generally positioned in a raised portionthereof such that when the pushbolt 190 is not deployed downward, thevessel remains in its native position when oriented between the contactmembers 1. Occlusion of the vessel 188 is achieved by pressing thepushbolt 190 down until the lower portion 191 engages the vessel 188when the vessel 188 is disposed between the contact members 1. Thisembodiment provides the ability to occlude the vessel 188 both proximaland distal to an arteriotomy 191 in the target vessel 188 at the site ofthe anastomosis. Referring to FIG. 37C, a similar embodiment is providedby a roller 192 or clip mechanism 193 which is affixed to one or bothcontact members 1, for example by a hinge 194, which is selectivelymovable, to contact the target vessel 188 at a point either proximal ordistal or both to the arteriotomy.

In addition to positioning the target vessel for performing theanastomosis as shown in FIGS. 26A through 26C above, sutures associatedwith the stabilizer may be used to occlude the vessel to permit theanastomosis to be performed in a bloodless field. Referring to FIGS. 38Aand 38B, an embodiment of the invention may have a flange 195 protrudingfrom the contact member 1 to permit silastic vessel loops or sutures 196to be drawn about the target vessel 197 and the flange 195. To occludethe vessel 197 the suture 196 is passed around the vessel 197 and drawntight around the flange 195. To facilitate occluding the vessel, asliding shaft 198 may be used to surround the sutures 197 such that thesuture lines 196 traverse the length of the sliding shaft 198 and extendout the bottom to surround the vessel 197. In one embodiment, as shownin FIG. 38B, the shaft 3 of the stabilizing means has a movable rod 198having suture guides 199 disposed therein or operably associatedtherewith for adjusting tension on the suture lines. The movable rod 198may be concentrically disposed within the shaft means 3 such thatdownward pressure on the shaft means 3 and upward pressure on thesliding shaft 196 draws tension on the sutures 196 to occlude the vessel197.

FIG. 39 shows modifications to the upper surface of contact members 1 a,1 b of the invention wherein fixtures 201 are adapted to provide aresting place or attachment point for other surgical instruments such asscissors 202, forceps 203, or sutures and suture needles 204.Preferably, the fixtures 201 are magnetic to facilitate retainingmetallic surgical instruments in conforming contact with the uppersurface of the contact member 1.

Referring to FIG. 40, the contact members 1 of the invention and/or theshaft means 3 to which the contact members 1 are attached may beprovided with one or more flexible joints 205 that permit positioning ofeither the contact members 1 or the shaft means 3 about an axis.Preferably, the flex joint 205 may be provided at the point where theshaft 3 engages the contact member 1 (not shown), at the point where theconnecting shaft 2 engages the shaft means 3, or at the point where theconnecting shaft 2 is attached to the contact members 1.

Thus, in the embodiment of FIG. 40, the flexible joint 205 provided atthe point where the connecting shaft 2 is attached to each contactmember 1 allows the connecting shaft 2 and the shaft means 3 to betilted about an axis which is perpendicular to the target vessel. Theflexible joint 205 provided at the point where the shaft means 3 isattached to the connecting shaft permits the shaft 3 to be tilted fromside-to-side relative to the connecting shaft 2. In the embodiment ofFIG. 40, or in the embodiments described herein having hinges orflexible joints, the hinges or flex joints may be replaced byconventional lockable joints 206, as shown in FIG. 41, that areselectively locked and unlocked mechanically as with forceps 207.

As can be seen, such occluders are similar to the stabilizing contactmembers 1 described in several other embodiments herein, and can beexpected to provide significant stabilization of the beating heart.These occluders can be used in conjunction with other stabilizing meansor independently. They may be placed beside, rather than upon, thecoronary artery to provide stabilization without occlusion, if desired.In like fashion, most of the contact members 1 of other embodiments willprovide some occlusion of blood flow if placed upon, rather than beside,the target vessel.

As will be described in individual embodiments below, the shaft means 3may be attached, to or comprised of, a conformable arm which is used toposition the contact members against the heart, and then to lock thestabilizing means in place once a stabilizing force has been exerted.The conformable arm is flexible and lockable and may have severalconfigurations including a plurality of links, segments, or universaljoints in serial configuration and having a cable fixture passed throughthe interior of the links which causes the entire conformable arm tobecome rigid by tightening the cable fixture. Also, the conformable armmay be comprised of a synthetic gel or polymer contained within aconformable cylindrical housing and which becomes rigid upon exposure tolight or heat, such as the commercially available Dymax 183-M. Where theshaft means 3 is further comprised of the conformable arm, theconformable arm may be attached directly to the connecting shaft 2 orthe contact members 1

Referring to FIG. 42, this embodiment of the invention is a means forstabilizing the beating heart wherein the shaft means is comprised of aflexible, lockable arm 208 having a plurality of interconnecting links209 which allow positioning of the flexible arm 208 in every directionuntil the desired configuration is achieved at which point the flexiblearm 208 may be locked into fixed configuration by tightening a cablefixture (not shown) attached to a cable 210 running axially through theinterconnecting links 209. Each interconnecting link is comprised of aball portion 211 and a receiving portion 212 such that the ball portion211 fits conformingly within the receiving portion 212. The proximate(uppermost) end of the flexible, lockable arm 208 can be attached to astable support, or to the retractor. In a preferred embodiment, theflexible, lockable arm 208 is a series of interconnecting links 209having a cable 210 running through the center of each interconnectinglink 209 such that when tension is exerted on the cable 210, theflexible, lockable arm 208 is fixed in a rigid position. FIG. 42 alsoshows an embodiment of the invention wherein the contact members 1 arecomprised of a pair of substantially parallel elements 1 a, 1 b whichare positioned to receive a simple snap fixture 213 which is affixed tothe surface of the heart. In this embodiment, the snap fixture 213 ispositioned between the two parallel elements 1 a, 1 b of the contactmember 1, in order to fix the position of the heart tissue relative tothe contact members 1. As in the above embodiment, the contact members 1are preferably oriented in a substantially parallel fashion with thetarget artery of the anastomosis passing therebetween. The snap fixtures213 are affixed to the heart by a suture, wherein the suture line 214may then also be attached to the contact member 1 via a notch, which mayform a one-way locking mechanism to secure the suture line 214, or maybe attached to a circular post disposed in the body of the contactmember 1 (not shown). The suture line 214 then may be tied through thenotch or to the post in the contact member 1, to the contact member 1 a,1 b itself, or to the connecting shaft 2 to more tightly secure theheart to the contact member 1. An additional advantage of thisembodiment is that the stabilizing means is actually affixed to thecardiac tissue via the suture line 214, such that when the heart ismoving laterally or downward the artery being stabilized remainsimmobile and the surface of the heart may be lifted using the shaftmeans 3.

FIG. 43 shows an alternate embodiment of the flexible lockable arm 208attached to a retractor and having a series of interconnecting linkscomprised of sphere joints 215 and cylindrical tubes 216 and which mayhave a tensioning cable traversing the length of the flexible, lockablearm as in the design of FIG. 42. Additionally, these embodiments mayhave other tensioning means such as an inflatable internal balloon 217that expands against the interior of the links rendering the individuallinks immobile, and thereby locking the entire arm 208 into a fixedposition.

Additionally, the flexible, lockable arm 208 may be provided by aplurality of curved or bent tubular segments 218 as shown in FIG. 44Athat are interconnected by an internal tensioning cable 210 or othertightening means. In the embodiment of FIG. 44A, the curved or benttubular segments 218 have interfacing surfaces 219 with teeth 220 suchthat when brought into conforming relationship, the curved tubularsegments 218 do not rotate relative to one another due to theinterlocking relationship of the teeth 220. See FIG. 44B. As above, theflexible lockable arm 208 is fixed in position by applying tension via acentrally disposed tensioning cable 210 or other tensioning means suchas a spring-loaded rod, bolt, or wire. The interconnection betweenadjoining segments 218 may also be facilitated by brushings 221 that aredisposed around the wire 210 and are shaped to fit within a recessedportion 222 of interfacing surface 219.

Referring to FIG. 45A, a continuously flexible, lockable arm 208 isprovided by a hollow flexible shaft 223 having a material 224 disposedwithin which may become semi-rigid or stiff by a variety of methods. Inuse, the contact members 1 are positioned at the desired orientationrelative to the beating heart, and the material 224 inside the flexibleshaft 223 is caused to be rendered stiff or semi-rigid. The material 224disposed within the flexible shaft 223 may be an epoxy-type glue, a lowmelting temperature metal with an electric heating wire 225 disposedtherein, a fine granular material or known chemicals which becomesemi-solid upon exposure to light, heat, or chemical means. Where a finegranular material is used, a mechanical compression fixture 226 orvacuum suction may be provided to compress the material 224 to cause theshaft 208 to become rigid.

Referring to FIG. 45B, additionally disposed within the flexible shafts223 may be a plurality of interconnected discs 227 which aresubstantially parallel and which engage the inner-surface of theflexible shaft 223. As with the above-described embodiments, the discs227 may be interconnected by a wire 210 running the length of the shaft.The plurality of discs 227 reduce shear forces across the flexible shaft223 and may provide separately activated sections that provide forselective stiffening of the flexible shaft along its length. As would beapparent to one of ordinary skill in the art, a flexible lockable shaftmay be provided by a hybrid of the various embodiments described herein,such that selective portions of the shaft may be rendered more or lessflexible as desired.

Referring to FIG. 46A, an adjustable shaft means 3 may also be providedby a plurality of adjustable links 228 that are connected to, orcomprise, the shaft means 3. Preferably, the adjustable links 228 arepositioned at the distal end of shaft means 3 and are connected to theconnecting shaft 2, or directly to the contact members 1. Referring toFIG. 46A, a plurality of curved or bent links are provided, preferablyat least three such links, which are independently adjustable to providemultiple rotational adjustments. The plurality of adjustable links 228provides a compact mechanism for positioning the contact members 1throughout a wide range of motion.

Referring to FIG. 46B, the links are independently rotatable relative tothe shaft means 3 and the shaft 2 connecting end contact members 1 andto each other. The assembly formed of the plurality of connected linksmay be lockable by providing an elastomers liquid or gas shreddedelastomer rubber, granulated plastic, or tint rubber metallic ballbearings hydraulic medium within the body of the links 228.

Referring again to FIG. 46A, an elastomeric hydraulic medium 229 isdisposed within the adjustable links. The point of interconnectionbetween the adjustable links may have internal or external retainingrings 230 a, 230 b and a means for compressing the elastomeric hydraulicmedium 229 that is operably associated with the interior of theadjustable links 228 such that a force can be exerted on the medium 229to pressurize the medium to lock each link 228 against the retainingrings 230 a, 230 b to fix the position of each adjustable link 228relative to the adjoining link, thereby locking the entire assembly ofthe shaft means 3 into position.

Referring to FIG. 46C, a means for compressing the elastomeric hydraulicmedium may be provided by a pushrod 231 that encounters the medium atits distal end, and which may be actuated by a handle 233 attached to ascrew 232 at the proximal end of the shaft means 3. The handle 233 has aspring 234 disposed about a piston to maintain a constant small forceupon the medium 229. The compression spring 234 in the proximal end ofthe shaft 3 provides a minimal preloaded force on the pushrod 231 in thesame direction as when the handle engages the pushrod with screw 232.The force provided by spring 234 allows repositioning of the contactmembers 1 in a non-locked state. Additionally, the handle 233 isthreaded into a housing 236 which is in turn threaded onto the shaft 3.Rotating the housing 236 on the threaded shaft 3 provides for anadjustment in the length of the shaft which in turn will adjust thepreload force that the above-mentioned spring maintains, as well as, theaxial position of the handle 233.

A flexible shaft may also be provided by the embodiment of FIG. 47having a plurality of substantially unstretchable strands 239 containedwithin a flexible outer shaft 240 that has a locking means comprised ofclamp 241 at the proximal end for compressing the strands 239 at theproximal end and thus fixing the position of the flexible shaft. Thus,by actuating the locking means comprised of clamp 241 the strands 239within the flexible shaft 240 are compressed against one another,preventing an individual strand from sliding relative to one another,thereby fixing the position of the plurality of strands 239 and lockingthe contact members 1 in place.

The interior of the flexible shaft 240 may be provided with severalflexible substances which may be rendered solid by chemical ormechanical means or may have sealed portions that cause the flexibleshaft 240 to become rigid or semi-rigid. For example, FIG. 48 has aflexible shaft 240 with a cable 210 running along its length andplurality of fluid-filled lumens 242 disposed therein. When the lumens242 are not sealed, the contact members 1 may be continuously positionedand the flexible shaft 240 set in any configuration. When the desiredorientation of the contact members 1 is achieved, the lumens 242 aresealed to fix the position of the flexible shaft 240. Additionally,these lumens 242 may be differentially pressurized or evacuated toadjust the position of contact members 1.

Referring to FIG. 49, a fine adjustment mechanism is provided by aplurality of threaded positioning cables 248 that traverse threadedports 244 of a proximal portion 243 of the shaft means 3 and about theperiphery of an end member 245 of the shaft. The end member 245 of theshaft 3 is positioned at each of the plurality of threaded ports 244 byturning the threaded cables 246. By rotating the cables by knobs 247,the portion of the end member 245 of the shaft is moved either upward ordownward relative to its original position.

FIG. 50A shows the interior of a shaft means 3 of the invention having aspring-loaded mechanism 249 in the proximal portion thereof for dampingthe vertical motion of the proximal end of an inner shaft 251. A spring252 is mounted within the interior of the proximal portion 253 of anouter shaft 254 such that when the contact members 1 are lowered ontothe beating heart, the proximal end 250 of inner shaft 251 gentlycompresses the spring 252. The outer shaft 254 may be positioneddownward until a point of resistance is met at which the beating heartachieves adequate stabilization. At that point, the outer shaft 254 maybe fixed in position, i.e., by attaching to the retractor or otherstabilized support 255 while the inner shaft 251 may move up and down ina vertical direction. The oscillation of the inner shaft 251 is dampenedby the spring 252 mounted in the proximal portion 253 of the outer shaft254 or may be rendered motionless by lower positioning of the outershaft 254 relative to the surface of the beating heart.

As shown in FIG. 50A, the spring mechanism 249 may also be mounted atthe distal portion of the shaft means 3 and the spring 252 may beexternal to a central shaft 256. An additional configuration (FIG. 50B)having a damped vertical motion is provided by a fluid-dampeningmechanism consisting of a chamber 257 with a seal 260 having a plunger258 for moving therein wherein said plunger has a piston 261 having anannular seal 261 a thereabout, such as a rubber O-ring seal, thatengages the internal portion of the chamber 257 to substantially sealthe passage of fluid. Piston 261 has one or more orifices 269 torestrict the flow of fluid therethrough. Additionally, inside plunger258 is a one-way valve such as a spring-loaded ball 258 a within abypass 258 b. As an upward vertical force is imparted upon the centralshaft 250, the fluid dampening mechanism restricts the ability of thecentral shaft 250 to move upward, while its downward motion isrelatively unrestricted, due to fluid flowing through bypass passage 258b.

Referring to FIG. 51A, the shaft means 3 depicted therein has anadjustable central shaft 263 with a fine adjust capability provided by athumbscrew 264 which is rotatable about a threaded portion 265 of thecentral shaft 263 and which is connected at the most distal end to thecontact members 1. Independent rotation of the central shaft 263 isprevented by a stop 268. As in FIG. 1, the shaft of this embodiment maybe rotatably attached to a portion of a retractor or stabilized support266 by passing the shaft through a ball and socket joint 267.

Referring to FIG. 51B, the contact members 1 are attached to a partialportion of the shaft means 3 comprised of an outer sleeve 269 thatextends to engage a second shaft 270 having a plurality of splines 271about the exterior. A first internal shaft 272 is attached to a balljoint 273 operably connected to the contact members 1. The firstinternal shaft 272 is disposed inside both the outer sleeve 269 and thesecond shaft 270 and has threads 274 to permit adjustment by a handle275 (which may be removable). At the end of the threaded internal shaft272, the ball joint 273 allows the contact members 1 to rotate at thebase of the shaft means 3. The second shaft 270 is engaged through theouter sleeve 269 by the splines 271 to keep the ball joint 273 fromrotating. A circular clip 275 has inner ridges 276 that pass through theouter sleeve 260 and maintain the ball joint 273 in a fixed position.

Referring to FIG. 52, a method for providing continuous and adjustablepositioning of the contact members 1 of the invention may be readilyprovided by a malleable shaft 277 which is attached to the contactmembers 1 and which may slide and be molded by hand. In particular, themalleable shaft 277 may slide through a fixture 278 attached to a stablesupport such as a retractor blade 279 used to open the surgicalincision. The vertical positioning of the device may be achieved by ahandle 280 which is manipulated from outside of the incision and causesa vertical portion 281 of the malleable shaft 277 to slide through thefixture 278.

Referring to FIG. 53, an embodiment for the shaft means 3 of theinvention is shown having a plurality of linked members 282, each ofwhich is connected to the adjacent linked member 282 by a hinge 283, anda torsion spring connected to each hinge (not shown) and which areinterconnected by a cable 284 connected to each linked member 282,preferably at an attachment point 285 adjacent to the hinges 283. Byproviding a plurality of discrete interconnected linked members 282 withan arcuate shape, and by providing an interconnecting cable 284, acurved shaft means 3 is provided with the ability to coil and uncoil asthe tension is exerted, released, or reversed, on the cable 284.Preferably, the most distal linked member 282 and the end of the cable284 is affixed to contact member(s) in any of the several embodimentsdescribed previously.

To take advantage of the minimally invasive procedures enabled by theinvention, the positioning of the contact members 1 by manipulation ofthe configuration of the shaft means 3 may be achieved remotely, i.e.,from outside the incision, by any of a variety of mechanisms attached toand operably associated with the shaft means 3. Referring to FIGS. 54Athrough 54C, remote manipulation of the positioning of the contactmembers 1 may be provided by a shaft means 3 having a ball joint 286 atthe distal end thereof which is connected to the contact members 1 orthe connecting shaft 2. Continuous positioning of the ball joint 286 maybe provided by a plurality of cables 287 which are affixed to the balljoint at opposing points 288 at the exterior surface of the ball joint286. The ball joint 286 is maintained in a socket 289 at the distal endof the shaft means 3. The shaft means 3 itself may be rigid or flexible,or may be fixed into a predetermined position by the surgeon dependingon the clinical environment. Additionally, the shaft means 3 may becomprised of a plurality of shafts, including an inner flexible shaft290 contained within a rigid shaft 291 wherein the flexible shaft 290extends above the rigid portion, terminating at the positioning handle292. The contact members 1 are positioned by means of the plurality ofcables 287 attached to the ball joint 286. The plurality of cables 287runs from the ball joint 286 through the length of the shaft means andterminate in a positioning handle 292 at the proximal end of the shaftmeans 3. The shaft 3 may be of any convenient length but is preferablylong enough to extend the positioning handle 292 to a point sufficientlybeyond the incision that manipulation of the position of the contactmembers 1 does not interfere with the surgeon's ability to visualize thesurgical site. Thus, each cable 287 has a distal portion affixed to theball joint 280, and a proximal portion affixed to a positioning handle292 having the cables attached thereto. In one configuration, theplurality of positioning cables 287 are affixed about a plurality ofattachment points 293, respectively, on the positioning handle 292.

In the embodiment of FIGS. 54B and 54C, the positioning handle 292 has arecessed area 295 in the bottom surface and a post 294 disposed in therecessed area 295 about which the cables 287 are affixed at severalpoints. The most proximal portion of the positioning handle 292 isadapted to be grasped by the hand and may be rotated about the post 294to provide selective tension on the cables 287, thereby repositioningthe contact members 1 at the distal end of the shaft means 3.

As is apparent from the foregoing description, an important function ofa shaft means is to selectively place the contact members at theappropriate site on the beating heart, while providing sufficientflexibility and positioning adjustability for different clinicalsituations and for different surgical access techniques. Also, the shaftis typically mounted or attached to a stable support at a proximal endand typically at a point outside the patient's chest. Thus, it isadvantageous to provide a shaft means having the ability to bepositioned in several configurations, particularly relative to a stablesupport such as a surgical retractor or access platform which is used toprovide access to the beating heart.

Referring to FIGS. 55A and 55B, because the available access and workingspace for the surgeon may be limited, certain embodiments of theinvention may be contained substantially within the chest cavity.Preferably, such a stabilizing means is connected to the rib retractorand may be affixed to one or both sides of the opening created byspreading the ribs using the rib retractor.

Referring to FIG. 55A, rib retractor 296 is shown in an open positionwhereby blades 297 engage and spread the ribs. A pair of stabilizingbars 298 having a conventional ratchet means 299 attached at the endthereof are positioned beneath the retractor. The ratchet means 299 iscomprised of a plurality of teeth 300 on the stabilizing bars 298 and aratcheting aperture 301 permitting one-way passage of the stabilizingbars 298 unless released by a release mechanism. The stabilizing bars298 are curved downward such that as the bars are advanced through theratchet means 299, the lowermost portion of the stabilizing bars 298engages the beating heart 301 a proximate to the anastomosis site.

Referring to FIG. 55B, the orientation of the portion of the stabilizingmeans, which engages the heart relative to the rib retractor 296 issimilar to the embodiment shown in FIG. 55A. In this embodiment, acontact member 1 is attached on opposite ends to at least two malleablesupports 302 which are in turn attached to the rib retractor 296. Themalleable supports 302 are preferably made of stainless steel bandswhich are woven in a mesh or have a repeating serpentine configurationto allow for substantial extension into the chest cavity. Thisconfiguration yields a malleable support 302 with sufficient tensilestrength to maintain a stabilizing force at the anastomosis site whileallowing the surgeon to manipulate the malleable supports 302 within thechest cavity to achieve the desired orientation relative to the beatingheart.

As noted above, at the upper end of the shaft means 3, the shaft means 3may be attached to a fixed support which may be any surface or structurewhich does not move with the beating heart. For example, the shaft means3 may be attached to a fixture on the retractor system used to spreadthe ribs for access to the heart or may be attached to a fixed structuresuch as the surgical table or associated aperture which is not connectedto the patient. In a preferred embodiment, the shaft means 3 is directlyattached to a component of the retractor system which is designed toreceive the shaft means 3 and to maintain the position and orientationof the shaft means 3 during the procedure.

Referring to FIGS. 56A and 56B, an adjustable slide mechanism isprovided to the shaft means 3 such that the shaft means can becontinuously positioned relative to a retractor. For example, in FIG.56A, a curved shaft 303 traverses a ball joint 304 disposed at the endof an adjustable arm 305 which connects the shaft means to the retractor306 and is lockable relative to the retractor 306. The curved shaft 303traverses the ball joint 304, as described previously, and is positionedby sliding the shaft 303 relative to the ball joint 304, providing theability for the contact members 1 to be positioned at any point within agiven arc as defined by the flexible shaft 303. Also, the entirely ofthe curved shaft 303 may be positioned in a perpendicular direction awayfrom the length of the retractor blade 307 using the adjustable arm 305.FIG. 56B shows a top view from LVI—LVI of the adjustable arm 305 whichmay have a slot or groove formed in the body thereof allowing continuouspositioning until the arm is fixed in position by a locking mechanism308. Thumbscrew 312 c locks the position of ball 304 in member in place.

In FIG. 56C, the shaft means 3 is comprised of a pair of parallel shafts309 and 310 which slide around an axle 311 disposed in a tighteningmechanism 312 affixed to the retractor 313. The position of the shaftmeans 3 relative to the retractor 313 is adjustable by sliding the shaftmeans 3 along the axle 311. Moving handle 311 a causes a correspondingmotion; in the contact members 1. Tightening thumbscrew 312 c locksclamp members 312 a, 312 b onto port 312 d and shafts 309, 310simultaneously.

Referring to FIG. 57, an adjustable arm may be provided for continuouslyadjusting the distance between the retractor or other stable support andthe shaft means of the means for stabilizing the beating heart of theinvention. At one end of the adjustable arm, the shaft means 3 traversea ball joint 314 which is contained in a socket 315 formed in the bodyof the adjustable arm. The tightness of the ball joint 314 may beadjusted by tightening a shaft 316 affixed to the socket 315 and whichpasses through the body 318 of the adjustable arm. The tightening shaft316 which is in turn connected to a rotating knob 319 that may tightenor loosen the ball joint 314 by tightening the socket 315 via thetightening shaft 316. The distance between the shaft means 3 and theball joint 314 is also adjustable relative to the stable support 320 byvirtue of a slit or groove 321 formed in the body of the adjustable arm.A locking mechanism 322 is disposed within the groove 321 such thatactuating a locking handle 323 fixes the position of the adjustable armby tightening the locking mechanism 322 about the groove 321.

FIGS. 58A, 58B, and 58C are multiple segment shaft means 3 havingalternate configurations to permit adjustable positioning. FIG. 58A hasan elbow joint 324 with a hinge attaching upper and lower dual shaftmembers 325 a, 325 b, and 326 a, 326 b, such that the upper and lowershafts members are continuously positioned relative to a retractor orother stable support 327. The assembly may be attached to the retractorand the lower dual blade shaft members 325 a, 325 b are attached to thecontact members by rotating joints 328 while the upper dual shaftmembers 326 a, 326 b are attached to the support by a second rotatingjoint 329. FIG. 58B has two shafts which are positioned to extend in ahorizontal plane by extending from beneath a retractor blade 330 and byrotating around at least one circular joint 331 disposed between a firstand second shaft 332 and 333. At the end of the second shaft 333, thecontact members 1 may be provided with a third vertical shaft 334 havinga ball joint 335 disposed at a proximal end thereof and which is affixedto the second shaft member 333.

One particularly useful feature of the shaft means of the invention isthe ability to extend the distal end of the shaft in a continuous ortelescopic fashion such that the contact members can be continuouslypositioned downwards relative to the proximal end of the shaft that isin turn attached to a retractor or other stable support. The degree ofdownward extension may be provided by several mechanical embodiments.FIG. 58C is a telescoping shaft member 336 having a lower shaft 337concentrically oriented within an upper shaft 338 and a locking means339 for fixing the position of the lower shaft 337 relative to the uppershaft 338. Additionally, the contact members 1 may be positioned bypivot 339 located at the proximal distal ends of the lower shaft 337.The upper shaft 338 may also be positioned relative to the retractorblade 330 by a tilting mechanism 340 that adjusts the angle of the uppershaft 338 relative to the retractor blade 330.

Referring to FIGS. 59A, 59B, and 59C, the stabilizing means of theinvention may be provided by a plurality of adjustable attachments thataffix the proximal end of a shaft or shafts to a retractor. For example,in FIG. 59A, a plurality of telescoping shaft means 341 are affixed toseveral pivoted joints 342 or hinges on a retractor blade 343 such thatthe contact members 1 can be continually positioned in three dimensionsrelative to the retractor blade 343 which grips one edge of an incision.When retracted, the contract members 1 are contained entirely within arecessed housing 343 a formed in the retractor blade 343.

In the embodiment of FIG. 59B, a lockable rotatable arm 344 is providedthat may be locked or unlocked to be positioned vertically by a firsthinge 345 and to swing or rotate around a second hinge 346 wherein bothhinges are mounted in a retractor arm or a retractor blade 343.

In FIG. 59C, the shaft means has an adjusting knob 347 affixed to theproximal end of a telescoping shaft means 348 at a point along theretractor arm 349 or the retractor blade 343. By loosening the adjustingknob 347, the telescoping shaft means 348 may be extended or retractedrelative to the retractor arm 349 and the retractor blade 343 therebyallowing the contact members 1 to swing into position to be brought intocontact with the beating heart.

In the embodiment of FIG. 60, a flexible central shaft 350 having ahandle 351 at the most proximal end is disposed within at least oneshaft guide 352, and preferably a series of shaft guides 352, 353, and354. The handle 351 is adapted to be held by the hand and allows bothrotation of the flexible central shaft 350 and positioning of thecontact members 1 by extension or retraction of the handle 351. Any ofthe series of shaft guides 352, 353, and 354 may be straight or formedto have a predetermined curve to alter the direction of the centralshaft 350. A proximal shaft guide 354 may be integral with a retractor355 used to open a surgical incision. A particularly preferred lowprofile embodiment of FIG. 60 has a shaft guide 354 integrallyassociated with a cross-member 356 that connects the arms of retractorblades 357. The shaft means 3 at the distal end of the central shaft 350may be straight or curved and rigid or flexible as desired. To fix theposition of the central shaft 350, a lock mechanism 358 is provided,preferably at a proximal portion of the central shaft 350, to fix theposition of the central shaft relative to the shaft guides 352, 353, and354.

Referring to FIG. 61, as noted above, attachment to a rib retractor is apreferred technique for fixing the position and orientation of thestabilizing means. The stabilizing means of the invention may thereforeadvantageously attached to a fixture attached to a rib retractor 359 ormay be configured to be directly incorporated into the body of a portionof the rib retractor 359. A surgical rib retractor 359 is generallycomprised of a body 360 having blades 361 attached thereto, which engagethe ribs and spread the ribs when the retractor, 359 is operated to movethe blades 361 apart from one another. The space created by theretracted blades 361 provides access to the heart. Thus, once theretractor 359 is locked into the open position, the stabilizing meansmay be applied to the heart and a stabilizing force maintained at thesite of the anastomosis by fixing the position and orientation of theshaft means 3 relative to the rib retractor 359. Referring again to FIG.61, the shaft means 3 may traverse the width of the body 360 of theretractor 359 and is held in place by an upper plate 362 and a lowerplate 363 having circular openings 364 therein through which the shaftmeans 3 passes and which maintain the position of a sphere 365positioned between the upper plate 362 and lower plate 363. The size ofthe openings 364 is larger than the diameter of the shaft means 3 butsmaller than the largest diameter of the sphere 365. Thus, the shaftmeans 3 passes through the sphere 365 and may pivot about a pointapproximately at the center of the sphere 365.

Referring to FIG. 62, the stabilizing means of the invention may beprovided by a shaft means 3 that extends from a cross-arm 366 connectingthe individual arms 367 of a,surgical retractor such that the shaftmeans 3 extends between the arms 367 attached to the retractor blades368 and below the level of the retractor blades 368 such that thecontact members 1 and separate shaft 369 is positioned beneath the levelof the retractor blades 368 and is generally contained within the chestcavity. This embodiment is a low profile design wherein a portion of theshaft means 3 extends into the chest cavity and has a secondsubstantially horizontal shaft 369 extending from the distal end 370thereof.

Referring to FIG. 63, the stabilizing means of the invention mayadvantageously be provided with a rib locking mechanism 371 affixed toeither side of a rib 372 r to form a stable support for shaft means 3that extends from the rib locking mechanism 371 into the chest cavity.The rib locking mechanism 371 is comprised of an adjustable post 373preferably disposed with a slot 376 formed in the body of the riblocking mechanism 371 and its positioned between two adjacent ribs 372r, 373 r and a blade 374 affixed to the opposite side of the rib 372 rmost adjacent to the incision. The position of the blade 374 isadjustable relative to the post 373 by sliding the mechanism 371 alongthe slot 376 and fixing it in place with a locking latch 373.

As noted herein, the embodiments of the stabilizing means of theinvention may also be used to position the heart to facilitateperforming the bypass surgery or any other cardiac procedure where theposition of the beating heart may be adjusted. Referring to FIG. 64, theembodiment of FIG. 63 may be utilized as a heart positioning devicerequiring only the modification that the shaft means 3 affixed to anidentical or equivalent rib locking mechanism 371 a and the contactmembers 1 have a length and tensile strength such that the contactmembers 1 can maintained in a position about the periphery of thebeating heart as desired.

In combination with the several designs for contact members and relatedfeatures described previously herein, the configuration and constructionof the element which is attached to the contact members principally theshaft means, may partially comprise the contact members and may beprovided in several alternative designs without departing from thespirit of the invention. As indicated previously, certain variations maydepend on the surgical demands of a particular procedure, and willdepend on the nature of the surgical incision(s) used to access thebeating heart. For example, some embodiments of the invention areparticularly useful where a minimally invasive incision is created, andthe procedure is performed by introducing instruments through a cannulaor a hollow shaft that provides access to the heart. FIGS. 65A through65D show an embodiment of the invention whereby a means for stabilizingthe beating heart is provided that is integral or closely associatedwith a hollow shaft 386 that defines a surgical field around the site ofthe anastomosis. In FIG. 65A a hollow shaft 386 is provided having alower cylindrical portion 387 that splits into two semi-cylindricalportions 388 and 388 b that define the surgical field for an anastomosisof a target vessel 389.

Preferably, the bottom surface 390 has an opening 391 through which thevessel 389 passes such that the vessel lies within the opening 391 andwithin the larger space created by splitting of the hollow shaft 386 tocreate the surgical field. In this embodiment, instruments may beintroduced either through the hollow shaft portion 386 of the device orthrough the split portion of the lower portion 387 of the shaft toprovide stabilization and access to the vessel 389. The opening actionof the lower portion 387 of the shaft may be provided by a rotatingshaft means 3 which, when rotated, forces the lower portion 387 to splitinto the semi-cylindrical portions 388 a and 388 b.

Referring to FIG. 65B, a unitary hollow shaft 392 may be provided thatcontacts the beating heart about the bottom surface 390, to provide thestabilization function, and has a plurality of openings 393 disposed inthe body 394 thereof. Preferably at least one passage 395 is provided inthe bottom surface 390 such that the target vessel 389 may be disposedwithin the passage 395. A second passage 396 may be provided in thebottom surface 390 of the unitary hollow shaft 392, preferably at anopposite end, such that the vessel may pass through the openings 395,396, or where a single opening is provided (not shown) the edge of thebottom surface opposite the opening 395 acts as an occluder. Largeropenings 397 in the body of the unitary shaft 392 may be provided toenable the surgeon to have access to the target 389 vessel through thebody of the unitary shaft 392.

FIG. 65C is a hollow shaft element 398 having formed therein a pair ofcontact members 1 of the type described previously, but which fold outfrom the body 399 of the shaft by virtue of a hinge or pivot 400 at thelower portion 401 of the shaft element 399. By folding out the contactmembers 1, which are maintained substantially integral to the shaftelement during insertion of the shaft element 398 through a surgicalincision, the contact members 1 engage the surface of the beating heartand provide the stabilization function. The surgeon may introduceinstruments through the hollow portion of the shaft element 398, or fromanother direction to achieve the anastomosis.

Referring to FIG. 65D, the application of the stabilizing force need notbe applied directly below the surgical field created by the shaftelement 398. The embodiment of FIG. 65D has an annular ring 402 formedin the bottom portion 391 of the shaft element 398 and that may rotateabout the axis provided by a rod 403 or the shaft means 3 passingthrough the wall of the shaft element 398, and which is affixed to theannular ring 402. By rotating the rod 403, the annular ring 402 rotatesout from under the bottom 391 of the shaft element 398, and may bepositioned to contact the surface of the beating heart in an annularfashion adjacent and tangent to the shaft element 398. As with otherembodiments described herein, the annular ring structure 402 thatapplies the stabilizing function may have at least one passage 464formed in the bottom surface such that the vessel 389 may be positionedtherein. The passage 464 may pass through the entirety of the ring 402making it a “C” or “V” shaped contact member (not shown), which willallow easy removal from the field after construction of the anastomosisfastening the graft to the heart. Alternatively, the ring structure 402may be cut or broken for removal if necessary.

Referring to FIG. 66, this embodiment of the stabilizing means iscomprised of an elongated sheath member 405 which wraps around the heartin a strap-like fashion to restrict the motion of the heart. Thisembodiment may be used with a thoracotomy providing surgical access, butis particularly useful when access to the beating heart is provided by asternotomy. The sheath member 405 is positioned to surround the heartand manipulated so that each end of the sheath member 405 extends out ofthe chest cavity through the sternotomy. If desired, at least one end ofeach sheath member 405 is attached to a retractor 406 to secure theposition of the sheath member 405. The sheath member 405 may have aplurality of support attachments 407 which engage the exterior of theheart to hold it in place. At the point where the support attachments407 contact the surface of the heart, the support attachments 407 mayhave friction means 4 (not shown) attached to the surface which is indirect contact with the heart. The support attachments 407 may have orbe comprised of fluid-filled members 408 which cushion the heart againstthe sheath member 405, and absorb the motion of the heart while it isstabilized. Where the sheath member 405 has one or more fluid-filledmembers 408, the sheath member 405 may also include at least one lumen409 for introduction of air or a biocompatible fluid to the inflatablemembers 408, which may be inflated separately or simultaneously. In theformer instance, a separate lumen 409 is provided for each inflatablemember 408. The insertion of the sheath member 405 into the chest cavitymay be performed while the inflatable members 408 are deflated and isachieved manually or by a conventional guide and/or guide wire. Each ofthe support attachments 407 may be permanently attached to the sheathmember 405 or may slide along the length of the sheath member 405.Alternatively, alone or in combination with other inflatable members,the inflatable member 408 is positioned immediately proximate to thetarget coronary artery to achieve a more localized stabilization. Thus,the inflatable members of the invention may lie next to, or maysurround, the heart of the target coronary artery and may have openingsor apertures placed in the body thereof through which surgicalprocedures are performed. An additional stabilizing force may be appliedwhen the inflatable member 408 fills the space between the heart and theenclosing structure, such as the pericardial ling or the back of theribs. When the inflatable member 408 is appropriately inflated, thetarget artery site may be pressed against a proximate stabilizingstructure, such as contact member 1, the back of edge of the surgicalincision. The fluid-filled or inflatable cushioning, stabilizing, orpositioning means could also be applied via a rigid, malleable,deformable, or removable shaft, handle, mounting, or inflation means.

Similarly, referring to FIG. 67, a strap 410 may be provided which isarranged to pass over opposite retractor blades 411, to pass underneaththe heart, and which may be mounted at both ends to a crank 412 forselective movement of the strap 411. By turning the crank 412, or byotherwise manipulating the position of the strap 411, the heart may berotated for selective positioning or to provide access to variousregions of the heart. The cranks 412 are advantageously attached to theretractor used to maintain spreading of the ribs in a minimally invasivethoracotomy.

As noted above, in addition to stabilization of the beating heart, thedevices and methods of the invention may be used as shown in FIGS. 66and 67 to selectively position the heart. Additionally, as shown in FIG.68, an alternate to a continuous strap 411 is shown in FIGS. 68A, 68B,and 68C and is comprised of a substantially flat, flexible sheet 413positioned under the heart. One side of the sheet 413 may have ahydrogel 414 coating, or a coating of a similar material that adheres tothe epicardial surface. Preferably, the other side of the sheet 413 issmooth. In a preferred embodiment, two sheets 413 are joined at theirrespective edges to form an interstitial space (not shown) therebetween.Perfusion of the interstitial space with fluid softens the hydrogel 414,allowing ready repositioning or removal of the sheets 413.

Depending on the nature of the surgical procedure, it may be desirableto lock the contact members 1 in place by manipulating their positionfrom a location remote from the surgical field. In the embodiment ofFIG. 69, a plurality of telescoping shafts 415 are provided which engagea contact member 1 at their most distal end. Preferably, each telescopicshaft 415 is affixed to a point on the retractor blade 416, therebyallowing the telescopic shafts 258 to be collectively adjustable toposition the contact members 1 at any point within the range of movementof the telescoping shafts 415 within the surgical field. At the mostproximal point of each telescopic shaft 258, the shaft is affixed to theretractor blade 416 by virtue of a hydraulic actuator 417 that fixes theorientation of each telescopic shaft 415 relative to the retractor blade416. Each hydraulic actuator 417 is attached to a lock valve 418 vianon-expanding hydraulic hoses 419. Typically, the lock valve comprises areservoir 420 and a hand-activated switch 421 for closing the lock valve418 to lock the hydraulic actuators 417 into position. Any number oftelescopic shafts 415 may be provided, however, it is preferable that aplurality of mounting points are available at various locations on theretractor blade 418 such that the surgeon can individually attachseveral, preferably at least three, telescopic shafts 415 to theretractor blades 416 at the locations best suited for each surgicalprocedure.

Referring to the embodiment of FIGS. 70A through 70D, a stabilizingmeans is provided with a shaft means 3 comprised of a plurality of armsconnected by joints having selectively placed friction surfacesassociated therewith that freeze the joints and adjustable arms into aset configuration when the contact members are displaced upwards by themotion of the beating heart. Referring to FIG. 70B, the retractor blade416 has a locking mechanism 422 with an internal cam shaft 422 aactuated by a handle 422 b that expands a first curved leaf spring 422 cto fix the position of a first shaft 424 relative to the retractor blade416. As shown in FIG. 70A, the first shaft 424 is attached to a firstfriction joint 425 permitting rotation of the joint about an axisperpendicular to first shaft 424. Referring to FIG. 70C, the frictionjoint 425 is comprised of a lower housing 426 affixed to the first shaft424 and an upper housing 427 affixed to a second shaft 428 which may bea discrete cylindrical shaft as the first or may be an extension of thehousing of the friction joint 425. A ball pivot 429 is positionedbetween the upper 427 and lower housing 426 to allow the individualhousings to rotate about each other. Either the upper 427 or lower 426housing has disposed therein a friction surface 430, and the oppositehousing has a friction engaging means such as teeth 431. When eitherhousing is displaced by tilting about the ball pivot 429, the frictionsurface 430 contacts the friction engaging means 431 and freezes theposition of the friction joint 425. The second shaft may be connected toa second friction joint 432 having an equivalent construction to thefirst.

Referring to FIGS. 70A and 70D, a rotatable shaft means 433 is comprisedof a central rod 434 disposed within a housing 438 having a ratchetingmechanism formed from tongues 435 engaging teeth around said central rod434 to fix the rotatable position of the rotatable shaft means 433. Therotatable shaft means 433 is connected to the contact members 1, forexample, by a hinge 436 having a shaft 439 resistant to rotation byteeth (not shown) engaged by molded tongues 437.

In the embodiment of FIGS. 71A through 71D, a retractor blade 440 isadapted to receive a clip into which is inserted a flexible slide havinga contractible shaft means at the distal end thereof and means forextending the contractible shaft. Referring first to FIG. 71C, theassembly includes a C-shaped clip 441 for attaching the stabilizingmeans to the retractor blade 440. The clip has at least one groove 442adapted to fit within a guide 443 formed in the retractor blade 440. Thebody of the clip 441 also has a slot 444 around the outside of thecurved portion as shown in FIGS. 71A and 71B and in phantom in FIG. 71Cfor insertion of a flexible slide 445. FIG. 71D shows the flexible slide445 that fits inside the, slot 444 formed in the clip 441 such that theflexible slide enters the clip 441 through the slot 444 and curvesaround to conform to the shape of the clip 441. A block 440 is mountedat the distal end of the flexible slide 445.

An extendable shaft means 447 is attached to the block 446 and has anunexpandable hydraulic tube 448 affixed thereto which is in fluidconnection with a syringe 449 or other such fluid containing apparatusto apply hydraulic pressure through the tube 448 to extend the shaftmeans 447. Preferably, the syringe has a one-way valve 450 with arelease valve 451 such that hydraulic fluid pressure is applied toprogressively advance the extendable shaft means 447, while the one-wayvalve 450 prevents the extendable shaft means 447 from contracting. Uponcompletion of the procedure, the hydraulic pressure is released byactivating release valve 451.

Referring to FIG. 71A, the surgeon would first insert the clip 441 ontothe retractor blade 440 by inserting the flexible slide 445 into theslot 444. The flexible slide 445 is thereby advanced from the top of theclip 441 through to the bottom until the extendable shaft means 447 isin position to be extended to bring the contact members 1 intoconforming engagement with the heart. With one hand, i e, via thesyringe 449, fluid is injected into the extendable shaft 447 to causethe contact members 1 to engage the heart. Note also that the guide 443in the retractor blade 440 may extend the length of the blade 455,allowing selective positioning of the clip 441 along the blade 440.

Referring to FIG. 72, the means for stabilizing the beating heart of theinvention is shown in use together with a rib retractor 452 andadditional apparatus 453, 454 which may be used during the beating heartCABG procedure. In use, the blades 455 of the retractor separate theribs, thereby providing an access space for the introduction of surgicalinstruments, including the stabilizing means of the invention. Thestabilizing means is thus brought into contact with the heart such thatthe contact members 1 are proximate to the target artery 456. Astabilizing force is exerted in an amount sufficient to minimize themotion of the beating heart, including fixing the stabilizing means inplace, preferably by attachment to the rib retractor 452.

Referring to FIG. 73, the stabilizing means is comprised of a pair ofrectangular, substantially planar contact members 1, which are placedproximate to a target artery 456. The shaft means 3 is conformable suchthat it may be conveniently attached to the rib retractor 452. As shownin FIG. 73, the surgeon may readily adjust the orientation andpositioning of the connecting shaft 2 and the contact members 1 relativeto the shaft means 3 while the stabilizing means is in continuouscontact with the heart by manipulating the thumbscrew 457 at theproximal end of the instrument. FIG. 74 shows a later stage of theprocedure at a point where the anastomosis is being completed bysuturing at target artery 456. The stabilizing means thus maintains astabilizing force at the anastomosis site for the duration of theprocedure.

As described above in several embodiments of the invention, thestabilizing means may advantageously be integrated with a relatedsurgical device such as a retractor that is used to spread the ribs inpreparation for the cardiac surgery. FIG. 75 is an embodiment of theinvention having a pair of shaft means 3 integrated with the arms of aretractor 459 suitable for spreading the ribs in a minimally invasivecardiac surgery. The stabilizing means are comprised of shafts havingadjustable links 459 as previously described that provide forpositioning of the contact members 1. The shaft means 3 also traverseball joints 460 that are directly affixed to the arm 458 of theretractor blade, and terminate with adjustable handles 460 for lockingthe position of the shaft means 3 and contact members 1 in place.

As mentioned previously, it is the goal of the present invention toprovide an apparatus, or collection of apparatus, to facilitatecompleting a minimally invasive CABG procedure on the beating heart.Thus, each of the devices disclosed herein is preferably provided in anintegrated kit, having several individual instruments packaged thereinto provide the surgeon with each of the instruments necessary tocomplete the anastomosis on the beating heart. Since it is intended thatthe means for stabilizing the beating heart as described herein, will beintroduced directly into the thoracic cavity, and brought into directphysical contact with the beating heart, it is necessary that each ofthe devices disclosed herein be subjected to the sterilizationtechniques suitable for other surgical instruments. It is particularlypreferred that a substantial portion of the devices described herein beformed of a biocompatible and sterilizable plastic and maintained in asterile container completely enclosing the instrument whereby thecontainer provides a barrier against microorganisms and wherein thestabilizer means of the invention and the container in which theinstruments are packaged are sterilized. Sterilization of the containerand the instruments contained therein may be provided by conventionalsterilization methods such as ETO gas, high temperature and pressure, orgamma radiation. Preferably, the container is a sealable flexible bagthat may be sterilized either before or after having the instruments ofthe invention sealed therein.

The particular examples set forth herein are instructional and shouldnot be interpreted as limitations on the applications to which those ofordinary skill are able to apply this invention. Modifications and otheruses are available to those skilled in the art which are encompassedwithin the spirit and scope of the following claims.

What is claimed is:
 1. A device for use in a cardiovascular surgery onthe beating heart comprising: a means for stabilizing the beating heartcomprising a contact member shapeable to conform to and engage thesurface of the beating heart; and adapted to stabilize the beating heartby exerting a mechanical stabilizing force on the exterior of the heart;and means for introducing a positive or negative pressure to saidcontact member to fix a shape of said contact member.
 2. A device foruse in a cardiovascular surgery on the beating heart comprising: a meansfor stabilizing the beating heart comprising a contact member shaped toengage the surface of the beating heart; and wherein said contact memberhas a hollow portion containing a conformable material therein.
 3. Thedevice of claim 2 wherein said conformable material is granular, apolymeric, or a gel.
 4. A device for use in a cardiovascular surgery onthe beating heart comprising: a means for stabilizing the beating heartcomprising a contact member shaped to engage the surface of the beatingheart; and wherein said contact member is formed of a single continuouswire.
 5. A device for use in a cardiovascular surgery on the beatingheart comprising: a means for stabilizing the beating heart comprising acontact member shaped to engage the surface of the beating heart; andwherein said contact member is inflatable.
 6. A device for use incardiovascular surgery on the beating heart, comprising: a shaft meansfor adjusting the position and orientation of said device, having adistal end portion and a proximal end portion; and at least onecontinuously adjustable contact member connected to said distal endportion of said shaft means for adjusting the position and orientationof said device, said at least one continuously adjustable contact membercomprising a flexible tube and adapted to be adjusted to change aconformation of said at least one continuously adjustable contact memberand to maintain the changed conformation, to substantially conform to asurface of the heart.
 7. The device of claim 6, wherein said at leastone continuously adjustable contact member is adapted to be bent into aU-shaped configuration.
 8. The device of claim 6, wherein said at leastone continuously adjustable contact member is configured for applicationof a vacuum thereto to substantially fix the at least one contact memberin its currently adjusted configuration.
 9. The device of claim 6,wherein said flexible tube contains a plurality of particles or beads.10. The device of claim 9, further comprising a vacuum lumen connectingwith said flexible tube, wherein upon application of vacuum through saidvacuum lumen, said particles or beads are compressed by atmosphericpressure causing said flexible tube to become substantially rigid. 11.The device of claim 9, further comprising a malleable member extendingalong at least a portion of a length of said flexible tube.
 12. Thedevice of claim 11, wherein said malleable member comprises a wire. 13.The device of claim 11, further comprising a plurality of disks disposedalong said malleable member.
 14. The device of claim 6, furthercomprising a malleable member extending along least a portion of alength of said flexible tube.
 15. The device of claim 14, wherein saidmalleable member comprises a wire.
 16. The device of claim 14, furthercomprising a plurality of disks disposed along said malleable member.17. The device of claim 6, wherein said flexible tube is inflatable. 18.The device of claim 6, wherein said at least one continuously adjustablecontact member comprises a pair of continuously adjustable contactmembers.
 19. The device of claim 18, wherein each of said pair ofcontinuously adjustable contact members comprises a flexible tube. 20.The device of claim 19, wherein each said flexible tube contains aplurality of particles or beads.
 21. The device of claim 20, furthercomprising a vacuum lumen connecting with each said flexible tube,wherein upon application of vacuum through said vacuum lumen, saidparticles or beads are compressed by atmospheric pressure causing saidflexible tubes to become substantially rigid.
 22. The device of claim21, further comprising a malleable member extending along least aportion of a length of each said flexible tube.
 23. The device of claim22, wherein each said malleable member comprises a wire.
 24. The deviceof claim 22, further comprising a plurality of disks disposed along eachsaid malleable member.
 25. The device of claim 19, wherein each saidflexible tube is inflatable.
 26. The device of claim 6, wherein said atleast one continuously adjustable contact member comprises a pluralityof continuously adjustable contact members.
 27. A device for use incardiovascular surgery on the beating heart, comprising: a shaft meanshaving a distal end portion, a proximal end portion, and a central lumendisposed therethrough; and a preformed inflatable member connected tosaid distal end portion of said shaft means, said preformed inflatablemember being inflatable to form a contact member adapted to contact asurface of the heart.
 28. The device of claim 27, further comprising aninsertion tube having an inside diameter allowing said shaft means topass therethrough, wherein, when said inflatable member is adapted topass through said insertion tube when in a deflated state, and isimpassable through said insertion tube when in an inflated state. 29.The device of claim 27, wherein said preformed inflatable member is aninflatable balloon.
 30. The device of claim 27, wherein said preformedinflatable member forms a pair of said contact members upon inflationthereof.
 31. A method of preparing a device for use in cardiovascularsurgery on the beating heart, wherein the device has at least onecontinuously adjustable contact member adapted to be adjusted tosubstantially conform to a surface of the heart, said method comprisingthe steps of: manipulating the at least one continuously adjustablecontact member into a desired configuration; and applying a vacuum tothe at least one continuously adjustable contact member to substantiallyfix the desired configuration.
 32. The method of claim 31, wherein thedevice is deployed for use in minimally invasive cardiovascular surgery,said method further comprising the steps of: prior to said manipulatinginto a desired configuration, manipulating the at least one continuouslyadjustable contact member into a configuration capable of passingthrough a minimally invasive opening providing access to the heart; andpassing the at least one continuously adjustable contact member throughthe minimally invasive opening which provides access to the heart.
 33. Amethod of deploying a device for use in minimally invasivecardiovascular surgery, wherein the device has a preformed inflatablemember which is inflatable to form a contact member adapted to contact asurface of the heart, said method comprising the steps of: passing saidinflatable member, in a deflated state through a minimally invasiveincision which provides access to the heart; inflating said inflatablemember to form the contact member; and contacting the surface of theheart with said contact member.
 34. The method of claim 33, wherein saidpassing step is performed by passing said inflatable member through aninsertion tube which is inserted through the minimally invasiveincision.
 35. A device for stabilizing a portion of a beating heartduring cardiovascular surgery, said device, comprising: a shaft meanshaving a distal end portion and a proximal end portion; and at least onecontinuously adjustable contact member adapted to be adjusted tosubstantially conform to a surface of the heart; and an opening in saidat least one continuously adjustable contact member through whichnegative pressure may be applied, wherein upon application of negativepressure, said at least one continuously adjustable contact membersubstantially rigidifies in a position to which said contact member wasadjusted at the time of application of vacuum.
 36. The device of claim35, wherein said at least one continuously adjustable contact member issubstantially U-shaped.
 37. The device of claim 36, further comprising ashaft means connected to said at least one continuously adjustablecontact member and extending therefrom.
 38. The device of claim 37,wherein said shaft means comprises a flexible, lockable arm.
 39. Thedevice of claim 35, wherein said at least one continuously adjustablecontact member contains a plurality of particles or beads.